HIV InfectionsNCT00608569
Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults
A study testing Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate and Tenofovir disoproxil fumarate in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 9 sites in 8 countries.
Trial summary
Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate and Tenofovir disoproxil fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Mar 2009to Sep 2012
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Have experienced or currently experiencing first baseline virologic failure on first NNRTI-based HAART regimen with no history of virologic failure on another regimen OR discontinued first NNRTI-based HAART regimen without the recommendations of clinicians and currently experiencing virologic failure with no history of virologic failure on another regimen. More information on this criterion can be found in the protocol.
- Confirmed virologic failure within 45 days of study entry
- Receiving one of the following NNRTI-based regimens for at least 16 weeks prior to study entry: ZDV+3TC+NVP, ZDV+3TC+EFV, d4T+3TC+NVP or d4T+3TC+EFV
- Able to identify a close friend, relative, or spouse who is willing to serve as a partner
- Intend to stay in current geographical area of residence for the duration of the study
Show all 27Show fewer
- Agree to use LPV/rtv with MEMS caps and take the tablets out of the container only at dosing
- Willing to use acceptable forms of contraception
- Ability and willingness of participant or legal guardian/representative to give written informed consent.
- Required laboratory values obtained within 45 days prior to study entry.
- Negative serum or urine pregnancy test obtained within 48 hours prior to study entry for women of reproductive potential.
- Not a participant
- Friend, family member, or spouse who knows of the participant's HIV status. Partners do not have to live with participants.
- Willing to attend a 1- to 2-hour taped training session prior to study entry
- Willing to attend study visits with participant at study screening; entry; and Weeks 4, 8, 12, 24, and 52
- Willing to directly observe participant taking at least one dose of LPV/rtv for at least 5 days per week for 24 weeks after stratification of participant
- Willing to act as a positive support for participant
- Willing to notify clinical staff of participant's nonadherence to study assigned regimen
- Willing to notify clinical staff if they are unable to provide mDOT for 2 weeks or more
- Willing to complete medication diary logs
- Willing to complete exit interview
- Agree to have their training session taped (if required).
- For mDOT arm, willing to discuss and decide with participants whether to continue mDOT after Week 24
- At least 18 years old
- Understand that participants have agreed to use LPV/RTV with MEMS caps and take the tablets out of the container only at dosing
- Ability and willingness to give written informed consent.
- No intention to relocate away from current geographical area of residence for the duration of study participation.
Who cannot join
- Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days of study entry
- Prior treatment with any PI
- Previously diagnosed cancer other than basal cell carcinoma and cutaneous Kaposi's sarcoma
- Use of rifampin or rifabutin within 45 days of study entry or plan use of rifampin or rifabutin
- Requirement for taking any medications that are prohibited by this study. More information on this criterion can be found in the protocol.
- Known allergy to the study medications or their formulations
Show all 18Show fewer
- Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study
- Acute illness requiring hospitalization within 14 days of study entry
- Active tuberculosis (TB) infection
- Currently incarcerated
- Participation as a partner in this study
- Participation with no access to telephones
- Abnormal laboratory values
- Pregnant, breastfeeding, or intend to become pregnant
- A participant in this study
- Participation as a partner to any other participant
- No access to telephones
- Currently incarcerated
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
Brazil1 site
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, 21045
About this study
Official title: International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen
Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.
Read the detailed description
Poor adherence to HAART is usually associated with resistant virus. Poor adherence to HAART can have serious consequences, including limited treatment options for HIV infected individuals if they become infected with resistant HIV. The purpose of this study was to examine the effectiveness of modified directly observed therapy (mDOT) and compare it with the effectiveness of self-administered therapy (non-mDOT) in HIV infected individuals with first virologic failure on an NNRTI-based HAART regimen who were starting a PI-based HAART regimen at study entry.
mDOT was defined in this study as the daily observation of lopinavir/ritonavir (LPV/r) being taken on a regular basis. Observation consisted of an mDOT partner being present at the time the study participant took the observed dose. Half of the participants in this study were required to choose an mDOT partner to supervise adherence for the first 24 weeks of the study. Each mDOT partner completed the study-administered mDOT training program and was required to record all observed doses in an mDOT diary log. All participants and partners received health education through the study. Adherence was measured using Medication Event Monitoring System (MEMS) caps and self-report questionnaires.
This study lasted 52 weeks. Per protocol, participants were to be stratified according to their screening viral load and the proposed study treatment. The study treatment each participant received was based on their treatment history. At entry, participants were to start one of the two PI-based HAART regimens, either FTC/Tenofovir Disoproxil Fumarate (TDF) 200/300 mg once daily (QD) and Lopinavir/Ritonavir (LPV/RTV) 400/100 mg twice a day (BID) or TDF 300 mg QD and zidovudine (ZDV) 300 mg BID and LPV/RTV 400/100 mg BID. mDOT was used for the first 24 weeks of the study, followed by self-administration of study medications from week 25 to week 52. ZDV was not provided by the study. All enrolled participants except one who did not start study regimen initiated FTC/TDF and LPV/rtv after randomization. No participants started ZDV containing regimen on study. Thus, participants in this study were stratified by screening HIV-1 RNA only.
There were eight visits during the study. Medical and medication history, blood collection, and clinical assessment were required at all visits. A quality of life questionnaire and an adherence tools assessment were collected at most visits. For the mDOT arm, medication diary logs and mDOT partner monitoring were reviewed at most visits. An mDOT exit questionnaire and exit interview were required at the end of the study.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate, Zidovudine, Emtricitabine
- Keywords
- Drug Therapy, Combination, HIV Non-Nucleoside Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, Viral Load, Virologic Failure
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/ritonavirDrug
Also called LPV/RTV, LPV/r, Kaletra
Two tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily
Emtricitabine/Tenofovir disoproxil fumarateDrug
Also called FTC/TDF, Truvada
200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily
Tenofovir disoproxil fumarateDrug
Also called TDF, Viread
300-mg tablet taken orally once daily
ZidovudineDrug
Also called ZDV, Retrovir
300-mg tablet taken orally twice daily
EmtricitabineDrug
Also called FTC, Emtriva
200-mg tablet taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| mDOT arm | Experimental | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks. Receives: Drug: Lopinavir/ritonavir; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Tenofovir disoproxil fumarate; Drug: Zidovudine; Drug: Emtricitabine |
| non-mDOT arm | Active comparator | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks. Receives: Drug: Lopinavir/ritonavir; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Tenofovir disoproxil fumarate; Drug: Zidovudine; Drug: Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Virologic Failure at or Prior to Week 48
Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.
Measured: At or prior to Week 48
Secondary outcomes (7)
Confirmed Virologic Failure at or Prior to Week 24
Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported.
Measured: At or prior to Week 24
CD4 Count at Follow-up Visits
CD4 cell count (median, inter-quartile range)
Measured: At Weeks 4, 12, 24, 36, and 48
CD8 Count at Follow-up Visits
CD8 cell count (median, inter-quartile range)
Measured: At week 4, 12, 24, 36, and 48
Time to First Grade 3 or 4 Lab Event
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event
Measured: 52 weeks since randomization
Time to First Grade 3 or 4 Sign or Symptom
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom
Measured: 52 weeks since randomization
Time to First Grade 3 or 4 Lab or Sign/Symptom Event
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event
Measured: 52 weeks since randomization
Adherence to Second Line HAART Regimen
Number of participants with self-reported 100% adherence over the week prior to study visit
Measured: At weeks 4, 8, 12, 24, 36, 48 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMar 2009
- Primary completionSep 2012
- Study completionSep 2012
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 (7)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Robert Gross, MD, MSCE, Study chair, University of PennsylvaniaAlberto La Rosa, MD, Study chair, Asociación Civil Impacta Salud y Educación, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608569
- Sponsor's protocol ID
- ACTG A5234
- Other IDs
- 1U01AI068636
- Status last verified
- Sep 2018
- First submitted
- 21 Jan 2008
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bangsberg DR, Kroetz DL, Deeks SG. Adherence-resistance relationships to combination HIV antiretroviral therapy. Curr HIV/AIDS Rep. 2007 May;4(2):65-72. doi: 10.1007/s11904-007-0010-0.
PubMed 17547827Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007 Jun 1;45 Suppl 1:S14-8. doi: 10.1097/QAI.0b013e3180600766.
PubMed 17525686Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. doi: 10.1177/003335490712200408.
PubMed 17639650Pearson CR, Micek MA, Simoni JM, Hoff PD, Matediana E, Martin DP, Gloyd SS. Randomized control trial of peer-delivered, modified directly observed therapy for HAART in Mozambique. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):238-44. doi: 10.1097/QAI.0b013e318153f7ba.
PubMed 17693890Mantshonyane L, Roy J, Levy MZ, Wallis CL, Bar K, Godfrey C, Collier A, LaRosa A, Zheng L, Sun X, Gross R. Participants Switching to Second-Line Antiretroviral Therapy with Susceptible Virus Display Inferior Adherence and Worse Outcomes: An Observational Analysis. AIDS Patient Care STDS. 2021 Dec;35(12):467-473. doi: 10.1089/apc.2021.0115. Epub 2021 Nov 16.
PubMed 34788110De Boni RB, Zheng L, Rosenkranz SL, Sun X, Lavenberg J, Cardoso SW, Grinsztejn B, La Rosa A, Pierre S, Severe P, Cohn SE, Collier AC, Gross R. Binge drinking is associated with differences in weekday and weekend adherence in HIV-infected individuals. Drug Alcohol Depend. 2016 Feb 1;159:174-80. doi: 10.1016/j.drugalcdep.2015.12.013. Epub 2015 Dec 24.
PubMed 26774947Gross R, Zheng L, La Rosa A, Sun X, Rosenkranz SL, Cardoso SW, Ssali F, Camp R, Godfrey C, Cohn SE, Robbins GK, Chisada A, Wallis CL, Reynolds NR, Lu D, Safren SA, Hosey L, Severe P, Collier AC; ACTG 5234 team. Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial. Lancet HIV. 2015 Jan;2(1):e12-9. doi: 10.1016/S2352-3018(14)00007-1. Epub 2014 Dec 11.
PubMed 26424232
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen
- ClinicalTrials.gov ID
- NCT00608569
- Acronym / sponsor ID
- ACTG A5234
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Non-Nucleoside Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, Viral Load, Virologic Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 15 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.
Detailed description
Poor adherence to HAART is usually associated with resistant virus. Poor adherence to HAART can have serious consequences, including limited treatment options for HIV infected individuals if they become infected with resistant HIV. The purpose of this study was to examine the effectiveness of modified directly observed therapy (mDOT) and compare it with the effectiveness of self-administered therapy (non-mDOT) in HIV infected individuals with first virologic failure on an NNRTI-based HAART regimen who were starting a PI-based HAART regimen at study entry.
mDOT was defined in this study as the daily observation of lopinavir/ritonavir (LPV/r) being taken on a regular basis. Observation consisted of an mDOT partner being present at the time the study participant took the observed dose. Half of the participants in this study were required to choose an mDOT partner to supervise adherence for the first 24 weeks of the study. Each mDOT partner completed the study-administered mDOT training program and was required to record all observed doses in an mDOT diary log. All participants and partners received health education through the study. Adherence was measured using Medication Event Monitoring System (MEMS) caps and self-report questionnaires.
This study lasted 52 weeks. Per protocol, participants were to be stratified according to their screening viral load and the proposed study treatment. The study treatment each participant received was based on their treatment history. At entry, participants were to start one of the two PI-based HAART regimens, either FTC/Tenofovir Disoproxil Fumarate (TDF) 200/300 mg once daily (QD) and Lopinavir/Ritonavir (LPV/RTV) 400/100 mg twice a day (BID) or TDF 300 mg QD and zidovudine (ZDV) 300 mg BID and LPV/RTV 400/100 mg BID. mDOT was used for the first 24 weeks of the study, followed by self-administration of study medications from week 25 to week 52. ZDV was not provided by the study. All enrolled participants except one who did not start study regimen initiated FTC/TDF and LPV/rtv after randomization. No participants started ZDV containing regimen on study. Thus, participants in this study were stratified by screening HIV-1 RNA only.
There were eight visits during the study. Medical and medication history, blood collection, and clinical assessment were required at all visits. A quality of life questionnaire and an adherence tools assessment were collected at most visits. For the mDOT arm, medication diary logs and mDOT partner monitoring were reviewed at most visits. An mDOT exit questionnaire and exit interview were required at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mDOT arm | Experimental | Drug: Lopinavir/ritonavir, Drug: Emtricitabine/Tenofovir disoproxil fumarate, Drug: Tenofovir disoproxil fumarate, Drug: Zidovudine, Drug: EmtricitabineOral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks. |
| non-mDOT arm | Active comparator | Drug: Lopinavir/ritonavir, Drug: Emtricitabine/Tenofovir disoproxil fumarate, Drug: Tenofovir disoproxil fumarate, Drug: Zidovudine, Drug: EmtricitabineOral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- HIV infected
- Have experienced or currently experiencing first baseline virologic failure on first NNRTI-based HAART regimen with no history of virologic failure on another regimen OR discontinued first NNRTI-based HAART regimen without the recommendations of clinicians and currently experiencing virologic failure with no history of virologic failure on another regimen. More information on this criterion can be found in the protocol.
- Confirmed virologic failure within 45 days of study entry
- Receiving one of the following NNRTI-based regimens for at least 16 weeks prior to study entry: ZDV+3TC+NVP, ZDV+3TC+EFV, d4T+3TC+NVP or d4T+3TC+EFV
- Able to identify a close friend, relative, or spouse who is willing to serve as a partner
Key exclusion criteria (18 listed)
- Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days of study entry
- Prior treatment with any PI
- Previously diagnosed cancer other than basal cell carcinoma and cutaneous Kaposi's sarcoma
- Use of rifampin or rifabutin within 45 days of study entry or plan use of rifampin or rifabutin
- Requirement for taking any medications that are prohibited by this study. More information on this criterion can be found in the protocol.
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 |
|---|---|---|
| Lopinavir/ritonavirAlso: LPV/RTV, LPV/r, KaletraTwo tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily | Drug | mDOT arm, non-mDOT arm |
| Emtricitabine/Tenofovir disoproxil fumarateAlso: FTC/TDF, Truvada200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily | Drug | mDOT arm, non-mDOT arm |
| Tenofovir disoproxil fumarateAlso: TDF, Viread300-mg tablet taken orally once daily | Drug | mDOT arm, non-mDOT arm |
| ZidovudineAlso: ZDV, Retrovir300-mg tablet taken orally twice daily | Drug | mDOT arm, non-mDOT arm |
| EmtricitabineAlso: FTC, Emtriva200-mg tablet taken orally once daily | Drug | mDOT arm, non-mDOT arm |
Primary outcome
Confirmed Virologic Failure at or Prior to Week 48
Time frame: At or prior to Week 48
Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.
7 secondary outcomes
Confirmed Virologic Failure at or Prior to Week 24
Time frame: At or prior to Week 24
CD4 Count at Follow-up Visits
Time frame: At Weeks 4, 12, 24, 36, and 48
CD8 Count at Follow-up Visits
Time frame: At week 4, 12, 24, 36, and 48
Time to First Grade 3 or 4 Lab Event
Time frame: 52 weeks since randomization
Time to First Grade 3 or 4 Sign or Symptom
Time frame: 52 weeks since randomization
Time to First Grade 3 or 4 Lab or Sign/Symptom Event
Time frame: 52 weeks since randomization
Adherence to Second Line HAART Regimen
Time frame: At weeks 4, 8, 12, 24, 36, 48 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17547827Bangsberg DR, Kroetz DL, Deeks SG. Adherence-resistance relationships to combination HIV antiretroviral therapy. Curr HIV/AIDS Rep. 2007 May;4(2):65-72. doi: 10.1007/s11904-007-0010-0.
- Background: PubMed 17525686Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007 Jun 1;45 Suppl 1:S14-8. doi: 10.1097/QAI.0b013e3180600766.
- Background: PubMed 17639650Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. doi: 10.1177/003335490712200408.
- Background: PubMed 17693890Pearson CR, Micek MA, Simoni JM, Hoff PD, Matediana E, Martin DP, Gloyd SS. Randomized control trial of peer-delivered, modified directly observed therapy for HAART in Mozambique. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):238-44. doi: 10.1097/QAI.0b013e318153f7ba.
- Derived from this study: PubMed 34788110Mantshonyane L, Roy J, Levy MZ, Wallis CL, Bar K, Godfrey C, Collier A, LaRosa A, Zheng L, Sun X, Gross R. Participants Switching to Second-Line Antiretroviral Therapy with Susceptible Virus Display Inferior Adherence and Worse Outcomes: An Observational Analysis. AIDS Patient Care STDS. 2021 Dec;35(12):467-473. doi: 10.1089/apc.2021.0115. Epub 2021 Nov 16.
- Derived from this study: PubMed 26774947De Boni RB, Zheng L, Rosenkranz SL, Sun X, Lavenberg J, Cardoso SW, Grinsztejn B, La Rosa A, Pierre S, Severe P, Cohn SE, Collier AC, Gross R. Binge drinking is associated with differences in weekday and weekend adherence in HIV-infected individuals. Drug Alcohol Depend. 2016 Feb 1;159:174-80. doi: 10.1016/j.drugalcdep.2015.12.013. Epub 2015 Dec 24.
- Derived from this study: PubMed 26424232Gross R, Zheng L, La Rosa A, Sun X, Rosenkranz SL, Cardoso SW, Ssali F, Camp R, Godfrey C, Cohn SE, Robbins GK, Chisada A, Wallis CL, Reynolds NR, Lu D, Safren SA, Hosey L, Severe P, Collier AC; ACTG 5234 team. Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial. Lancet HIV. 2015 Jan;2(1):e12-9. doi: 10.1016/S2352-3018(14)00007-1. Epub 2014 Dec 11.
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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.
Robert Gross, MD, MSCE study chair
University of Pennsylvania
Alberto La Rosa, MD study chair
Asociación Civil Impacta Salud y Educación, Peru
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate and Tenofovir disoproxil fumarate in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 9 sites in 8 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 27 inclusion and 18 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Peru, Botswana, Brazil, Haiti, South Africa and 3 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2013). 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?
Confirmed Virologic Failure at or Prior to Week 48 (time frame: At or prior to Week 48). 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 NCT00608569, which also lists 7 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 12 Oct 2018.