HIV InfectionsPhase 3NCT00074581
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
A Phase 3 study testing Atazanavir, Didanosine and Efavirenz in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in 9 countries.
Trial summary
This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Atazanavir, Didanosine and Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,526 participants
- Where
- 17 sitesin 9 countries
- Study dates
- Feb 2005to May 2015
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Positive HIV test within 60 days of study entry
- CD4 count between 350 and 550 cells/mm3 within 30 days of study entry
- If pregnant or breastfeeding, willing to be randomized to either arm of the study
- Negative HIV test within 14 days of study entry
- Plans to maintain sexual relationship with partner
- Reports having sex (vaginal or anal) with partner at least three times in the last 3 months
- Willing to disclose HIV test results to partner
- Plans to stay in the area and does not have a job or other obligations that may require long absences during the duration of the study
Who cannot join
- Current or previous use of any ART. Participants who previously took a short-term course of ART for prevention of mother-to-child transmission of HIV are not excluded.
- Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine or atazanavir
- Current or previous AIDS-defining illness or opportunistic infection
- Documented or suspected acute hepatitis within 30 days prior to study entry
- Acute therapy of serious medical illnesses within 14 days prior to study entry
- Radiation therapy or systemic chemotherapy within 45 days prior to study entry
Show all 16Show fewer
- Immunomodulatory or investigational therapy within 30 days prior to study entry
- Active drug or alcohol dependence that, in the opinion of the investigator, would interfere with the study
- Vomiting or inability to swallow medications
- Require certain medications
- Allergy or sensitivity to any of the study drugs
- History of injection drug use within 5 years of study entry
- Previous and/or current participation in an HIV vaccine study
- Currently detained in jail or for treatment of a psychiatric or physical illness
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- Certain abnormal laboratory values
Trial locations and contacts
17 sites in 9 countries.
17 sites in 9 countries
Brazil4 sites
Hospital Geral de Nova Iguaçu CRS (HGNI CRS)
Nova Iguaçu, Rio de Janeiro, 26030-380
Hospital Nossa Senhora da Conceicao CRS
Port Alegre, Rio Grande do Sul, 91350 200
HSE-Hospital dos Servidores do Estado CRS
Rio de Janeiro, 20221-903
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, 21040-360
India4 sites
Chennai Antiviral Research and Treatment (CART) CRS
Chennai, Tamil Nadu, 600113
NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS
Pune, Maharashtra, 411002
NARI Clinic at NIV CRS
Pune, Maharashtra, 411011
NARI Pune CRS
Pune, Maharashtra, 411026
South Africa2 sites
Soweto HPTN CRS
Johannesburg, Gauteng, 2001
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
Johannesburg, Gauteng, 2092
United States1 site
Fenway Community Health Ctr. CRS
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
Read the detailed description
Initiation of antiretroviral therapy (ART) in the HIV infected population has been shown to dramatically reduce the morbidity and mortality of HIV infection through sustained reduction in HIV viral replication. However, such therapy does not cure HIV infection or prevent the spread of the virus. ART may, however, make HIV infected people less contagious by lowering plasma HIV-1 RNA levels, compared with people not on ART. This study seeks to determine whether initiating ART in ART-naive, HIV infected people can prevent the sexual transmission of HIV among HIV-discordant couples, as well as to demonstrate whether quality of life changes with the initiation of ART. Both opposite and same sex couples will be recruited at study sites in Brazil, India, Malawi, Thailand, the United States, and Zimbabwe for this study.
Participating couples will be enrolled for approximately 78 months (6.5 years). Couples will be randomly assigned to one of two arms. HIV infected partners in Arm 1 will begin ART in addition to receiving HIV primary care. HIV infected partners in Arm 2 will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. All couples will receive HIV counseling and have their urine and blood collected at screening and enrollment, and at selected monthly, quarterly, and yearly intervals. They will be asked to periodically report information about their adherence to the ART regimen.
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
- Conditions
- HIV Infections
- Being tested
- Atazanavir, Didanosine, Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate, Lamivudine
- Keywords
- HIV Infections, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Also called Reyataz
300 mg taken orally once daily
DidanosineDrug
Also called Videx
400 mg taken orally once daily
EfavirenzDrug
Also called Sustiva
600 mg taken orally once daily
Emtricitabine/Tenofovir disoproxil fumarateDrug
Also called Truvada
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
LamivudineDrug
Also called Epivir, 3TC
300 mg taken orally once daily
Lopinavir/RitonavirDrug
Also called Kaletra
200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
NevirapineDrug
Also called Viramune, NVP
200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
StavudineDrug
Also called Zerit, d4T
Dosage depends on weight
Tenofovir disoproxil fumarateDrug
Also called Viread, TDF
300 mg taken orally once daily
Zidovudine/LamivudineDrug
Also called Combivir
150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will begin ART in addition to receiving HIV primary care Receives: Drug: Atazanavir; Drug: Didanosine; Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nevirapine; Drug: Stavudine; Drug: Tenofovir disoproxil fumarate; Drug: Zidovudine/Lamivudine |
| 2 | Experimental | Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible. Receives: Drug: Atazanavir; Drug: Didanosine; Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nevirapine; Drug: Stavudine; Drug: Tenofovir disoproxil fumarate; Drug: Zidovudine/Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.
Measured: Throughout study
All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2003 (estimated)
- Study startFeb 2005
- Primary completionMay 2015
- Study completionMay 2015
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 (8)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,526 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Prevention Trials Network
- Responsible party
- Sponsor
- Investigators
- Myron S. Cohen, MD, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074581
- Sponsor's protocol ID
- HPTN 052
- Other IDs
- 10068
- Status last verified
- Nov 2016
- First submitted
- 16 Dec 2003
- Last updated
- 5 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Chan DJ. Fatal attraction: sex, sexually transmitted infections and HIV-1. Int J STD AIDS. 2006 Oct;17(10):643-51. doi: 10.1258/095646206780071018.
PubMed 17059632Chan DJ. Factors affecting sexual transmission of HIV-1: current evidence and implications for prevention. Curr HIV Res. 2005 Jul;3(3):223-41. doi: 10.2174/1570162054368075.
PubMed 16022655Davis CW, Doms RW. HIV transmission: closing all the doors. J Exp Med. 2004 Apr 19;199(8):1037-40. doi: 10.1084/jem.20040426. Epub 2004 Apr 12. No abstract available.
PubMed 15078894Gupta K, Klasse PJ. How do viral and host factors modulate the sexual transmission of HIV? Can transmission be blocked? PLoS Med. 2006 Feb;3(2):e79. doi: 10.1371/journal.pmed.0030079. Epub 2006 Feb 28.
PubMed 16492075Odero I, Ondeng'e K, Mudhune V, Okola P, Oruko J, Otieno G, Akelo V, Gust DA. Participant satisfaction with clinical trial experience and post-trial transitioning to HIV care in Kenya. Int J STD AIDS. 2019 Jan;30(1):12-19. doi: 10.1177/0956462418791946. Epub 2018 Aug 29.
PubMed 30157702Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.
PubMed 27424812Grinsztejn B, Hosseinipour MC, Ribaudo HJ, Swindells S, Eron J, Chen YQ, Wang L, Ou SS, Anderson M, McCauley M, Gamble T, Kumarasamy N, Hakim JG, Kumwenda J, Pilotto JH, Godbole SV, Chariyalertsak S, de Melo MG, Mayer KH, Eshleman SH, Piwowar-Manning E, Makhema J, Mills LA, Panchia R, Sanne I, Gallant J, Hoffman I, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Havlir D, Cohen MS; HPTN 052-ACTG Study Team. Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis. 2014 Apr;14(4):281-90. doi: 10.1016/S1473-3099(13)70692-3. Epub 2014 Mar 4.
PubMed 24602844Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
PubMed 21767103
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
- ClinicalTrials.gov ID
- NCT00074581
- Acronym / sponsor ID
- HPTN 052
- Conditions
- HIV Infections
- Keywords
- HIV Infections, HIV Seronegativity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,526 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Prevention Trials Network
- Study start
- Feb 2005
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Dec 2003 (estimated)
- Results
- Posted 31 Oct 2016
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 determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
Detailed description
Initiation of antiretroviral therapy (ART) in the HIV infected population has been shown to dramatically reduce the morbidity and mortality of HIV infection through sustained reduction in HIV viral replication. However, such therapy does not cure HIV infection or prevent the spread of the virus. ART may, however, make HIV infected people less contagious by lowering plasma HIV-1 RNA levels, compared with people not on ART. This study seeks to determine whether initiating ART in ART-naive, HIV infected people can prevent the sexual transmission of HIV among HIV-discordant couples, as well as to demonstrate whether quality of life changes with the initiation of ART. Both opposite and same sex couples will be recruited at study sites in Brazil, India, Malawi, Thailand, the United States, and Zimbabwe for this study.
Participating couples will be enrolled for approximately 78 months (6.5 years). Couples will be randomly assigned to one of two arms. HIV infected partners in Arm 1 will begin ART in addition to receiving HIV primary care. HIV infected partners in Arm 2 will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. All couples will receive HIV counseling and have their urine and blood collected at screening and enrollment, and at selected monthly, quarterly, and yearly intervals. They will be asked to periodically report information about their adherence to the ART regimen.
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Atazanavir, Drug: Didanosine, Drug: Efavirenz, Drug: Emtricitabine/Tenofovir disoproxil fumarate, Drug: Lamivudine, Drug: Lopinavir/Ritonavir, Drug: Nevirapine, Drug: Stavudine, Drug: Tenofovir disoproxil fumarate, Drug: Zidovudine/LamivudineParticipants will begin ART in addition to receiving HIV primary care |
| 2 | Experimental | Drug: Atazanavir, Drug: Didanosine, Drug: Efavirenz, Drug: Emtricitabine/Tenofovir disoproxil fumarate, Drug: Lamivudine, Drug: Lopinavir/Ritonavir, Drug: Nevirapine, Drug: Stavudine, Drug: Tenofovir disoproxil fumarate, Drug: Zidovudine/LamivudineParticipants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Positive HIV test within 60 days of study entry
- CD4 count between 350 and 550 cells/mm3 within 30 days of study entry
- If pregnant or breastfeeding, willing to be randomized to either arm of the study
- Negative HIV test within 14 days of study entry
- Plans to maintain sexual relationship with partner
Key exclusion criteria (16 listed)
- Current or previous use of any ART. Participants who previously took a short-term course of ART for prevention of mother-to-child transmission of HIV are not excluded.
- Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine or atazanavir
- Current or previous AIDS-defining illness or opportunistic infection
- Documented or suspected acute hepatitis within 30 days prior to study entry
- Acute therapy of serious medical illnesses within 14 days prior to study entry
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 |
|---|---|---|
| AtazanavirAlso: Reyataz300 mg taken orally once daily | Drug | 1, 2 |
| DidanosineAlso: Videx400 mg taken orally once daily | Drug | 1, 2 |
| EfavirenzAlso: Sustiva600 mg taken orally once daily | Drug | 1, 2 |
| Emtricitabine/Tenofovir disoproxil fumarateAlso: Truvada200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily | Drug | 1, 2 |
| LamivudineAlso: Epivir, 3TC300 mg taken orally once daily | Drug | 1, 2 |
| Lopinavir/RitonavirAlso: Kaletra200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily | Drug | 1, 2 |
| NevirapineAlso: Viramune, NVP200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily | Drug | 1, 2 |
| StavudineAlso: Zerit, d4TDosage depends on weight | Drug | 1, 2 |
| Tenofovir disoproxil fumarateAlso: Viread, TDF300 mg taken orally once daily | Drug | 1, 2 |
| Zidovudine/LamivudineAlso: Combivir150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily | Drug | 1, 2 |
Primary outcome
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Time frame: Throughout study
incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.
All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Time frame: Throughout study
All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17059632Chan DJ. Fatal attraction: sex, sexually transmitted infections and HIV-1. Int J STD AIDS. 2006 Oct;17(10):643-51. doi: 10.1258/095646206780071018.
- Background: PubMed 16022655Chan DJ. Factors affecting sexual transmission of HIV-1: current evidence and implications for prevention. Curr HIV Res. 2005 Jul;3(3):223-41. doi: 10.2174/1570162054368075.
- Background: PubMed 15078894Davis CW, Doms RW. HIV transmission: closing all the doors. J Exp Med. 2004 Apr 19;199(8):1037-40. doi: 10.1084/jem.20040426. Epub 2004 Apr 12. No abstract available.
- Background: PubMed 16492075Gupta K, Klasse PJ. How do viral and host factors modulate the sexual transmission of HIV? Can transmission be blocked? PLoS Med. 2006 Feb;3(2):e79. doi: 10.1371/journal.pmed.0030079. Epub 2006 Feb 28.
- Derived from this study: PubMed 30157702Odero I, Ondeng'e K, Mudhune V, Okola P, Oruko J, Otieno G, Akelo V, Gust DA. Participant satisfaction with clinical trial experience and post-trial transitioning to HIV care in Kenya. Int J STD AIDS. 2019 Jan;30(1):12-19. doi: 10.1177/0956462418791946. Epub 2018 Aug 29.
- Derived from this study: PubMed 27424812Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.
- Derived from this study: PubMed 24602844Grinsztejn B, Hosseinipour MC, Ribaudo HJ, Swindells S, Eron J, Chen YQ, Wang L, Ou SS, Anderson M, McCauley M, Gamble T, Kumarasamy N, Hakim JG, Kumwenda J, Pilotto JH, Godbole SV, Chariyalertsak S, de Melo MG, Mayer KH, Eshleman SH, Piwowar-Manning E, Makhema J, Mills LA, Panchia R, Sanne I, Gallant J, Hoffman I, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Havlir D, Cohen MS; HPTN 052-ACTG Study Team. Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis. 2014 Apr;14(4):281-90. doi: 10.1016/S1473-3099(13)70692-3. Epub 2014 Mar 4.
- Derived from this study: PubMed 21767103Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
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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.
Myron S. Cohen, MD study chair
University of North Carolina, Chapel Hill
17 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atazanavir, Didanosine and Efavirenz in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 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 8 inclusion and 16 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Brazil, India, Malawi, South Africa, United States 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 31 Oct 2016). 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?
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (time frame: Throughout study). 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 NCT00074581, which also lists 8 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 5 Nov 2021.