HIV InfectionPhase 4NCT00955968
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
A Phase 4 study testing Highly active antiretroviral therapy (HAART) in people with HIV Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 50 sites in 9 countries.
Trial summary
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infection
- What is being tested?
- Highly active antiretroviral therapy (HAART)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,653 participants
- Where
- 50 sitesin 9 countries
- Study dates
- 1 Jan 2010to 31 Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age ≥ 18 years or who had attained the minimum age of independent consent, as defined by the local Institutional Review Board (IRB), and were willing and able to provide written informed consent Additionally, at sites with IRB approval to enroll younger participants, women age 16-17 years who were willing and able to provide written assent and whose parent or legal guardian was willing and able to provide written informed consent
- Confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry, using protocol-specified tests (see protocol for more details)
- Documentation of hepatitis B surface antibody (HBsAb) status and hepatitis B surface antigen (HBsAg) status (if antibody was negative) within 12 months prior to study entry
- Within 0-42 days after pregnancy outcome
- Antiretroviral treatment naïve, defined as < 14 days of one or more antiretroviral agents, prior to therapy initiated during current pregnancy
- Receipt of at least four weeks of HAART prior to study entry, at least two weeks of which must have been prior to pregnancy outcome (up to seven consecutive days of missed therapy is permitted)
Show all 16Show fewer
- CD4+ cell count ≥ 400 cells/mm^3 on a specimen obtained within 120 days prior to initiation of HAART for current pregnancy
- CD4+ cell count ≥ 400 cells/mm^3 on a specimen obtained on HAART and within 45 days prior to study entry
- The following laboratory values on a specimen obtained within 45 days prior to study entry:
- Absolute neutrophil count ≥ 750/mm^3
- Hemoglobin ≥ 7.0 g/dL
- Platelet count ≥ 50,000/mm^3
- AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 2.5 x ULN
- Estimated creatinine clearance of ≥ 60mL/min within 45 days prior to entry using the Cockcroft-Gault formula
- Intent to remain in current geographical area of residence for the duration of the study
- Willingness to attend study visits as required by the study
Who cannot join
- Previous participation in PROMISE (P1077BF - NCT01061151)
- Clinical indication for HAART including any World Health Organization (WHO) Clinical Stage 3 or 4 condition, prior or current tuberculosis disease (a positive (Purified protein Derivative) PPD test alone was not considered exclusionary), and/or any other clinical indication per country-specific treatment guidelines
- Clinically significant illness or condition requiring systemic treatment and/or hospitalization within 30 days prior to study entry
- Social or other circumstances which, in the opinion of the site investigator, would hinder long-term follow up
- Use of any prohibited medications within 14 days prior to study entry (refer to the study MOP for a list of prohibited medications)
- Current compulsory detention (involuntary incarceration) in a correctional facility, prison, or jail for legal reasons or compulsory detention in a medical facility for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Show all 9Show fewer
- Currently breastfeeding or planning to breastfeed
- Current documented conduction heart defect (specialized assessments to rule out this condition were not required; a heart murmur alone and/or type 1 second-degree atrioventricular block (also known as Mobitz I or Wenckebach) was not considered exclusionary)
- Known evidence of HBV DNA levels >2000 IU/mL (approximately 10,000 copies/mL) in the presence of elevated (grade 1 and higher) ALT (HBV DNA testing was not required for study screening or enrollment but was considered to determine whether treatment for HBV was indicated)
Trial locations and contacts
50 sites in 9 countries.
50 sites in 9 countries
United States26 sites
University of Southern California MCA Center (5048)
Alhambra, California, 90007
University of Colorado (5052)
Aurora, Colorado, 80045
Johns Hopkins University School of Medicine (5092)
Baltimore, Maryland, 21287
Boston Medical Center (5011)
Boston, Massachusetts
Ann & Robert H Lurie Children's Hospital of Chicago (4001)
Chicago, Illinois
Wayne State University/Children's Hospital of Michigan (5041)
Detroit, Michigan
Duke University Medical Center (4701)
Durham, North Carolina
Children's Diagnostic and Treatment Center (5055)
Fort Lauderdale, Florida
Baylor College of Medicine Texas Children's Hospital (3801)
Houston, Texas
University of Florida at Jacksonville (5051)
Jacksonville, Florida
David Geffen School of Medicine at UCLA (5112)
Los Angeles, California, 90095
St Jude Children's Research Hospital (6501)
Memphis, Tennessee
University of Miami Pediatric/Perinatal Clinical Research Site (4201)
Miami, Florida
Tulane University (5095)
New Orleans, Louisiana
Metropolitan Hospital (5003)
New York, New York, 10029
Pitt CRS (1001)
Pittsburgh, Pennsylvania, 15213
UCSD Mother-Child-Adolescent HIV Program (4601)
San Diego, California, 92093
Seattle Children's Hospital (5017)
Seattle, Washington
SUNY Stony Brook University Medical Center (5040)
Stony Brook, New York
University of South Florida at Tampa (5018)
Tampa, Florida
Bronx-Lebanon Hospital Center (5114)
The Bronx, New York
Jacobi Medical Center (5013)
The Bronx, New York
Harbor (UCLA) Medical Center (5045)
Torrance, California, 90505
Howard University (5044)
Washington D.C., District of Columbia, 20059
Georgetown University (1008)
Washington D.C., District of Columbia
Washington Hospital Center (5023)
Washington D.C., District of Columbia
Brazil8 sites
School of Medicine, University of Minas Gerais - FUNDEP (5073)
Belo Horizonte
University Caxias do Sul (5084)
Caxias do Sul
Hospital Nossa Senhora da Conceicao (5117)
Porto Alegre
Hospital Santa Casa (5098)
Porto Alegre
Hospital dos Servidores do Estado (5072)
Rio de Janeiro
Hospital Geral De Nova Igaucu (5097)
Rio de Janeiro
Instituto de Puericultura E Pediatria Martagao Geseira - FUJB (5071)
Rio de Janeiro
Ribeirao Preto Medical School, University of Sao Paulo (5074)
São Paulo
Thailand7 sites
Siriraj Hospital Mahidol University CRS (5115)
Bangkok, Ratchathewi,, 10700
Bhumibol Adulyadej Hospital (5124)
Bangkok
Prapokklao Hospital (5123)
Chanthaburi, 22000
Chiang Mai University (31784)
Chiang Mai, 50200
Chiang Rai Regional Hospital (5116)
Chiang Rai
Chonburi Hospital (5125)
Chon Buri, 20000
Phayao Provincial Hospital (5122)
Phayao, 56000
Botswana2 sites
Gaborone Prevention/Treatment Clinical Research Site (12701)
Gaborone
Molepolole Prevention/Treatment Clinical Research Site (12702)
Gaborone
Peru2 sites
IMPACTA Barranco Clinical Research Site (11301)
Lima
IMPACTA San Miguel Clinical Research Site (11302)
Lima
Puerto Rico2 sites
San Juan City Hospital (5031)
San Juan, 00927
University of Puerto Rico Pediatric HIV/AIDS Research Program (6601)
San Juan
China1 site
Guangxi Center for HIV/AIDS Prevention and Control (30274)
Nanning, Guangxi
About this study
Official title: IMPAACT 1077HS: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.
Read the detailed description
This randomized strategy trial addressed therapeutic questions for women from regions where antepartum HAART for PMTCT (for all CD4+ cell counts) and postpartum formula feeding is standard of care, and who also had both a pre-HAART CD4+ cell count >400 cells/mm^3 and a screening (on-HAART) CD4+ cell count > 400 cells/mm^3. For these women, the objectives related to the relative efficacy and safety of continuing HAART (when it is no longer used for PMTCT) versus discontinuing HAART.
Potential participants were identified/recruited and consented during pregnancy or after delivery or other pregnancy outcome. Study-specific screening was initiated in the third trimester or after pregnancy outcome. Women who were screened for the study were counseled to continue their HAART until they were randomized.
Randomization would occur within 0-42 days after pregnancy outcome. Women who did not carry their pregnancy to the third trimester but otherwise meet study eligibility criteria could be enrolled.
Participants were randomized to one of the two study arms:
Arm A: Continuation of HAART Arm B: Discontinuation of HAART and resume HAART when protocol-specified criteria were met
Participants were to be followed until 84 weeks after the last participant was randomized.
Key evaluations were conducted at Screening, Entry, post entry visits were scheduled to take place 4 weeks after entry, 12 weeks after entry, and every 12 weeks thereafter. Key evaluations included physical examinations, clinical assessments, and blood collection.
On 7 July 2015, the study sites received formal communications regarding the results of the Strategic Timing of Antiretroviral Treatment (START) study and associated changes were implemented to the 1077HS study in response to these results. All sites were instructed that all women in the 1077HS study were to be informed of the START study results and that antiretroviral therapy (ART) was recommended for all women based on the START study results.
- Conditions
- HIV Infection
- Being tested
- Highly active antiretroviral therapy (HAART)
- Keywords
- HIV Infection, HAART, Maternal Health
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly active antiretroviral therapy (HAART)Drug
A combination of three or more HIV medications belonging to two or more drug classes.
The preferred study-supplied HAART regimen was lopinavir/ritonavir (LPV/RTV) plus fixed dose combination tenofovir/emtricitabine (TDF/FTC). Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose combination tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV), didanosine (ddI), atazanavir (ATV), raltegravir (RAL), and ritonavir (RTV). While LPV/RTV plus TDF/FTC was the preferred study-supplied regimen, the study clinicians in conjunction with participants would determine the optimal drug combination for each participant.
| Study group | Role | What they receive |
|---|---|---|
| Continue HAART | Experimental | Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome. Receives: Drug: Highly active antiretroviral therapy (HAART) |
| Stop HAART | Active comparator | Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met. Receives: Drug: Highly active antiretroviral therapy (HAART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death
AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Secondary outcomes (19)
Incidence Rate of AIDS - Defining Illness
AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event
Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Deaths
The incidence rate was obtained by using the Kaplan-Meier method.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of HIV/AIDS Related Events
HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of HIV/AIDS Related Events or Death
HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events
HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Grade 2 and Above Toxicity
The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method.
Measured: All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up)
Incidence Rate of Cardiovascular or Other Metabolic Events
This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Other Targeted Medical Conditions
This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death
This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.
Measured: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm
VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2)
Measured: At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks.
Medication Adherence - Last Time Missed Medications
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Measured: week 0, 48 and 96
Medication Adherence - How Closely Followed Schedule
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Measured: week 0, 48 and 96
Medication Adherence - How Often Follow Instructions
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Measured: week 0, 48 and 96
Medication Adherence - Missed Dose Within Past 4 Days
Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Measured: week 0, 48 and 96
Quality of Life - General Health Outcome
Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Measured: week 0, 48 and 96
Quality of Life (QoL) - Health Rating Score
QoL - health rating score was evaluated by a self reported questionnaire. Health rating score of 0 was indicative of death or worst possible health and a score of 100 was being in perfect or best possible health and the mean of score is calculated. Higher scores indicate better Quality of Life (QoL). The range is 0-100 units on a scale
Measured: week 0, 48 and 96
Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers
This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.
Measured: Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Cost Effectiveness and Feasibility of Treatment Models
This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.
Measured: Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study start1 Jan 2010
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,653 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Judith S. Currier, MD, MS, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955968
- Sponsor's protocol ID
- IMPAACT 1077HS
- Other IDs
- U01AI068632
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2009
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 with Clarification dated August 2009, which can be found on the DAIDS RSC Web site: http://rsc.tech-res.com
Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0, January 2010.
Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, Santos B, Aurpibul L, Losso M, Pierre MF, Weinberg A, Gnanashanmugam D, Chakhtoura N, Klingman K, Browning R, Coletti A, Mofenson L, Shapiro D, Pilotto J; 1077HS PROMISE Team. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 >/= 400 cells/mm3. PLoS One. 2017 May 10;12(5):e0176009. doi: 10.1371/journal.pone.0176009. eCollection 2017.
PubMed 28489856
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPAACT 1077HS: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study
- ClinicalTrials.gov ID
- NCT00955968
- Acronym / sponsor ID
- IMPAACT 1077HS
- Conditions
- HIV Infection
- Keywords
- HIV Infection, HAART, Maternal Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,653 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.
Detailed description
This randomized strategy trial addressed therapeutic questions for women from regions where antepartum HAART for PMTCT (for all CD4+ cell counts) and postpartum formula feeding is standard of care, and who also had both a pre-HAART CD4+ cell count >400 cells/mm^3 and a screening (on-HAART) CD4+ cell count > 400 cells/mm^3. For these women, the objectives related to the relative efficacy and safety of continuing HAART (when it is no longer used for PMTCT) versus discontinuing HAART.
Potential participants were identified/recruited and consented during pregnancy or after delivery or other pregnancy outcome. Study-specific screening was initiated in the third trimester or after pregnancy outcome. Women who were screened for the study were counseled to continue their HAART until they were randomized.
Randomization would occur within 0-42 days after pregnancy outcome. Women who did not carry their pregnancy to the third trimester but otherwise meet study eligibility criteria could be enrolled.
Participants were randomized to one of the two study arms:
Arm A: Continuation of HAART Arm B: Discontinuation of HAART and resume HAART when protocol-specified criteria were met
Participants were to be followed until 84 weeks after the last participant was randomized.
Key evaluations were conducted at Screening, Entry, post entry visits were scheduled to take place 4 weeks after entry, 12 weeks after entry, and every 12 weeks thereafter. Key evaluations included physical examinations, clinical assessments, and blood collection.
On 7 July 2015, the study sites received formal communications regarding the results of the Strategic Timing of Antiretroviral Treatment (START) study and associated changes were implemented to the 1077HS study in response to these results. All sites were instructed that all women in the 1077HS study were to be informed of the START study results and that antiretroviral therapy (ART) was recommended for all women based on the START study results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue HAART | Experimental | Drug: Highly active antiretroviral therapy (HAART)Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome. |
| Stop HAART | Active comparator | Drug: Highly active antiretroviral therapy (HAART)Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Women age ≥ 18 years or who had attained the minimum age of independent consent, as defined by the local Institutional Review Board (IRB), and were willing and able to provide written informed consent Additionally, at sites with IRB approval to enroll younger participants, women age 16-17 years who were willing and able to provide written assent and whose parent or legal guardian was willing and able to provide written informed consent
- Confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry, using protocol-specified tests (see protocol for more details)
- Documentation of hepatitis B surface antibody (HBsAb) status and hepatitis B surface antigen (HBsAg) status (if antibody was negative) within 12 months prior to study entry
- Within 0-42 days after pregnancy outcome
- Antiretroviral treatment naïve, defined as < 14 days of one or more antiretroviral agents, prior to therapy initiated during current pregnancy
Key exclusion criteria (9 listed)
- Previous participation in PROMISE (P1077BF - NCT01061151)
- Clinical indication for HAART including any World Health Organization (WHO) Clinical Stage 3 or 4 condition, prior or current tuberculosis disease (a positive (Purified protein Derivative) PPD test alone was not considered exclusionary), and/or any other clinical indication per country-specific treatment guidelines
- Clinically significant illness or condition requiring systemic treatment and/or hospitalization within 30 days prior to study entry
- Social or other circumstances which, in the opinion of the site investigator, would hinder long-term follow up
- Use of any prohibited medications within 14 days prior to study entry (refer to the study MOP for a list of prohibited medications)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highly active antiretroviral therapy (HAART)A combination of three or more HIV medications belonging to two or more drug classes. The preferred study-supplied HAART regimen was lopinavir/ritonavir (LPV/RTV) plus fixed dose combination tenofovir/emtricitabine (TDF/FTC). Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose combination tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV), didanosine (ddI), atazanavir (ATV), raltegravir (RAL), and ritonavir (RTV). While LPV/RTV plus TDF/FTC was the preferred study-supplied regimen, the study clinicians in conjunction with participants would determine the optimal drug combination for each participant. | Drug | Continue HAART, Stop HAART |
Primary outcome
Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
19 secondary outcomes
Incidence Rate of AIDS - Defining Illness
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Deaths
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of HIV/AIDS Related Events
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of HIV/AIDS Related Events or Death
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Grade 2 and Above Toxicity
Time frame: All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up)
Incidence Rate of Cardiovascular or Other Metabolic Events
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Other Targeted Medical Conditions
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death
Time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm
Time frame: At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks.
Medication Adherence - Last Time Missed Medications
Time frame: week 0, 48 and 96
Medication Adherence - How Closely Followed Schedule
Time frame: week 0, 48 and 96
Medication Adherence - How Often Follow Instructions
Time frame: week 0, 48 and 96
Medication Adherence - Missed Dose Within Past 4 Days
Time frame: week 0, 48 and 96
Quality of Life - General Health Outcome
Time frame: week 0, 48 and 96
Quality of Life (QoL) - Health Rating Score
Time frame: week 0, 48 and 96
Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers
Time frame: Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Cost Effectiveness and Feasibility of Treatment Models
Time frame: Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundU.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 with Clarification dated August 2009, which can be found on the DAIDS RSC Web site: http://rsc.tech-res.com
- BackgroundManual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0, January 2010.
- Derived from this study: PubMed 28489856Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, Santos B, Aurpibul L, Losso M, Pierre MF, Weinberg A, Gnanashanmugam D, Chakhtoura N, Klingman K, Browning R, Coletti A, Mofenson L, Shapiro D, Pilotto J; 1077HS PROMISE Team. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 >/= 400 cells/mm3. PLoS One. 2017 May 10;12(5):e0176009. doi: 10.1371/journal.pone.0176009. eCollection 2017.
- Related InfoLink provided by the sponsor.
- WHO Case Definitions of HIV for Surveillance and Revised Clinical Staging and Immunological Classification of HIV-related Disease in Adults and Children (World Health Organization 2007).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith S. Currier, MD, MS study chair
University of California, Los Angeles
50 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Highly active antiretroviral therapy (HAART) in people with HIV Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 50 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Brazil, Thailand, Botswana, Peru and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death (time frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955968, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.