HIVPhase 4SABES?NCT01815580
HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women
A Phase 4 study testing Atripla or Stribild in people with HIV, run by Fred Hutchinson Cancer Center at 1 site in Peru.
Trial summary
This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Atripla or Stribild
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 sitePeru
- Study dates
- Jul 2013to 30 Jun 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men who have sex with men, and transgender women
- Unaware of HIV status at enrollment in follow-up cohort
- High risk for HIV infection
- Willing to test for HIV
- No prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days
- Willing to provide informed consent
Who cannot join
- Prior receipt of investigational anti-HIV vaccine
- Ongoing therapy with any of the following:
- Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed
- Systemic chemotherapeutic agents
- Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine
- Immunomodulatory treatments including Interleukin-2
Show all 12Show fewer
- Investigational agents
- Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations
- Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- Serious medical or psychiatric illness that would interfere with the ability to adhere to study requirements
- Chronic or acute hepatitis B infection
- Use of female hormonal products based on estrogen or derivatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people.
In this study, one group will be randomized (like a coin toss) to start ART immediately (just at the time of the enrollment visit) and the other group will wait until week 24 of the study to start ART. Both groups will be followed for a total of 48 weeks and will continue to receive ART from local sources after the study is over.
Read the detailed description
This is three-step study. Step 1 will screen men who have sex with men (MSM) and transgender women who are unaware of their HIV status and 1) report high risk behaviors for acquiring HIV-1 infection or 2) who have symptoms of acute retroviral syndrome or 3) who have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing will be conducted for several thousand MSM and transgender women from study opening until July 2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for acquiring HIV will be tested at regular intervals for incident HIV-1 (using tests for HIV p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation criteria.) All participants will be followed for 48 weeks after which they will continue ART from other sources.
- Conditions
- HIV
- Being tested
- Atripla or Stribild
- Keywords
- HIV, Treatment as Prevention, Seek, Test, Treat, Retain Strategies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atripla or StribildDrug
Also called (alternate: Truvada + 3rd ARV)
Antiretroviral therapy
| Study group | Role | What they receive |
|---|---|---|
| Immediate ART (Atripla or Stribild) | Active comparator | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment. Receives: Drug: Atripla or Stribild |
| Deferred ART (Atripla or Stribild) | Placebo comparator | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks. Receives: Drug: Atripla or Stribild |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With HIV Viral Load Suppression in Plasma
To quantify HIV viral load suppression (<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was <1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was <1000 copies/mL etc.
Measured: Baseline, Week 12, Week 24, Week 36, and Week 48
Number of Participants With HIV Viral Load Suppression in Semen
To quantify HIV viral load suppression (<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks
Measured: Baseline, Week 12, and Week 24
Secondary outcomes (9)
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
Measured: HIV diagnosis visit
Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
Measured: HIV diagnosis visit
Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care
To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care.
Measured: within 3 months of diagnosis of acute HIV infection
Partner Tracing
Partner tracing and notification
Measured: within 3 months of diagnosis
Number of Participants Retained in Care
To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48
Measured: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to ART Regimen (Percentage of Pills Taken)
To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation.
Measured: 48 weeks
Adherence to Viral Load (VL) Procedure
To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48
Measured: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to CD4 Procedure
To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48
Measured: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to Questionnaires
To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48
Measured: Baseline, Week 12, Week 24, Week 36, and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startJul 2013
- Primary completion30 Nov 2020
- Study completion30 Jun 2021
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 HIVStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Civil Impacta Salud y Educación, Peru, Asociación Civil Via Libre, Peru, Epicentro, Peru, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ann C Duerr, Fred Hutchinson Cancer Center
- Investigators
- Ann Duerr, M.D., Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815580
- Sponsor's protocol ID
- TNT-Peru
- Other IDs
- R01DA032106
- Acronym
- SABES?
- Status last verified
- Sep 2022
- First submitted
- 15 Mar 2013
- Last updated
- 29 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bachman VF, Montano MA, Ulrich A, Villaran M, Cabello R, Gonzalez P, Sanchez H, Lama JR, Duerr A. Correlates of condomless anal intercourse with different types of sexual partners among men who have sex with men and transgender women in Lima, Peru. AIDS Care. 2023 Jun;35(6):791-799. doi: 10.1080/09540121.2021.1994517. Epub 2021 Oct 26.
PubMed 34702087Mayer ME, White E, Montano MA, Lama JR, Sanchez H, Cabello R, Sanchez J, Pasalar S, Duerr A. Sexual Behavior Among Men Who Have Sex With Men: The Need for More Targeted Outreach to Men Who Also Have Sex With Cisgender Women. J Acquir Immune Defic Syndr. 2021 Mar 1;86(3):265-270. doi: 10.1097/QAI.0000000000002568.
PubMed 33148993Lama JR, Ignacio RAB, Alfaro R, Rios J, Cartagena JG, Valdez R, Bain C, Barbaran KS, Villaran MV, Pilcher CD, Gonzales P, Sanchez J, Duerr A. Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study. Clin Infect Dis. 2021 Mar 15;72(6):1042-1050. doi: 10.1093/cid/ciaa167.
PubMed 32107526
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
- ClinicalTrials.gov ID
- NCT01815580
- Acronym / sponsor ID
- SABES? / TNT-Peru
- Conditions
- HIV
- Keywords
- HIV, Treatment as Prevention, Seek, Test, Treat, Retain Strategies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Asociación Civil Impacta Salud y Educación, Peru, Asociación Civil Via Libre, Peru, Epicentro, Peru, National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2013 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Posted 29 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people.
In this study, one group will be randomized (like a coin toss) to start ART immediately (just at the time of the enrollment visit) and the other group will wait until week 24 of the study to start ART. Both groups will be followed for a total of 48 weeks and will continue to receive ART from local sources after the study is over.
Detailed description
This is three-step study. Step 1 will screen men who have sex with men (MSM) and transgender women who are unaware of their HIV status and 1) report high risk behaviors for acquiring HIV-1 infection or 2) who have symptoms of acute retroviral syndrome or 3) who have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing will be conducted for several thousand MSM and transgender women from study opening until July 2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for acquiring HIV will be tested at regular intervals for incident HIV-1 (using tests for HIV p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation criteria.) All participants will be followed for 48 weeks after which they will continue ART from other sources.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate ART (Atripla or Stribild) | Active comparator | Drug: Atripla or StribildDaily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment. |
| Deferred ART (Atripla or Stribild) | Placebo comparator | Drug: Atripla or StribildDaily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult men who have sex with men, and transgender women
- Unaware of HIV status at enrollment in follow-up cohort
- High risk for HIV infection
- Willing to test for HIV
- No prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days
Key exclusion criteria (12 listed)
- Prior receipt of investigational anti-HIV vaccine
- Ongoing therapy with any of the following:
- Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations
- Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- Serious medical or psychiatric illness that would interfere with the ability to adhere to study requirements
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 |
|---|---|---|
| Atripla or StribildAlso: (alternate: Truvada + 3rd ARV)Antiretroviral therapy | Drug | Deferred ART (Atripla or Stribild), Immediate ART (Atripla or Stribild) |
Primary outcome
Number of Participants With HIV Viral Load Suppression in Plasma
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
To quantify HIV viral load suppression (<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was <1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was <1000 copies/mL etc.
Number of Participants With HIV Viral Load Suppression in Semen
Time frame: Baseline, Week 12, and Week 24
To quantify HIV viral load suppression (<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks
9 secondary outcomes
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Time frame: HIV diagnosis visit
Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters
Time frame: HIV diagnosis visit
Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care
Time frame: within 3 months of diagnosis of acute HIV infection
Partner Tracing
Time frame: within 3 months of diagnosis
Number of Participants Retained in Care
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to ART Regimen (Percentage of Pills Taken)
Time frame: 48 weeks
Adherence to Viral Load (VL) Procedure
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to CD4 Procedure
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to Questionnaires
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34702087Bachman VF, Montano MA, Ulrich A, Villaran M, Cabello R, Gonzalez P, Sanchez H, Lama JR, Duerr A. Correlates of condomless anal intercourse with different types of sexual partners among men who have sex with men and transgender women in Lima, Peru. AIDS Care. 2023 Jun;35(6):791-799. doi: 10.1080/09540121.2021.1994517. Epub 2021 Oct 26.
- Derived from this study: PubMed 33148993Mayer ME, White E, Montano MA, Lama JR, Sanchez H, Cabello R, Sanchez J, Pasalar S, Duerr A. Sexual Behavior Among Men Who Have Sex With Men: The Need for More Targeted Outreach to Men Who Also Have Sex With Cisgender Women. J Acquir Immune Defic Syndr. 2021 Mar 1;86(3):265-270. doi: 10.1097/QAI.0000000000002568.
- Derived from this study: PubMed 32107526Lama JR, Ignacio RAB, Alfaro R, Rios J, Cartagena JG, Valdez R, Bain C, Barbaran KS, Villaran MV, Pilcher CD, Gonzales P, Sanchez J, Duerr A. Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study. Clin Infect Dis. 2021 Mar 15;72(6):1042-1050. doi: 10.1093/cid/ciaa167.
- 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.
Ann Duerr, M.D. principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atripla or Stribild in people with HIV, run by Fred Hutchinson Cancer Center at 1 site in Peru.
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 6 inclusion and 12 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 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. 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. Some participants in this study may receive a placebo. 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 29 Sep 2022). 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?
Number of Participants With HIV Viral Load Suppression in Plasma (time frame: Baseline, Week 12, Week 24, Week 36, and Week 48). The study lists 2 primary outcomes in all. 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 NCT01815580, 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 29 Sep 2022.