Back to resultsPreventing Sexual Transmission of HIV With Anti-HIV Drugs
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atazanavir
Didanosine
Efavirenz
Emtricitabine/Tenofovir disoproxil fumarate
Lamivudine
Lopinavir/Ritonavir
Nevirapine
Stavudine
Tenofovir disoproxil fumarate
Zidovudine/Lamivudine
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Infections, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria for HIV Infected Partner: 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 Inclusion Criteria for HIV Uninfected Partner: Negative HIV test within 14 days of study entry Inclusion Criteria for Both Partners: 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 Exclusion Criteria for HIV Infected Partner: 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 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 Exclusion Criteria for Both Partners: 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
Sites / Locations
- Fenway Community Health Ctr. CRS
- Gaborone CRS
- Hospital Geral de Nova Iguaçu CRS (HGNI CRS)
- Hospital Nossa Senhora da Conceicao CRS
- HSE-Hospital dos Servidores do Estado CRS
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
- NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS
- NARI Clinic at NIV CRS
- NARI Pune CRS
- Chennai Antiviral Research and Treatment (CART) CRS
- Kisumu Crs
- Blantyre CRS
- Malawi CRS
- Soweto HPTN CRS
- Wits Helen Joseph Hospital CRS (Wits HJH CRS)
- CMU HIV Prevention CRS
- Parirenyatwa CRS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Participants will begin ART in addition to receiving HIV primary care
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00074581
First Posted
December 16, 2003
Last Updated
November 3, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
HIV Prevention Trials Network
1. Study Identification
Unique Protocol Identification Number
NCT00074581
Brief Title
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
HIV Prevention Trials Network
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Infections, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3526 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will begin ART in addition to receiving HIV primary care
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Other Intervention Name(s)
Reyataz
Intervention Description
300 mg taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Didanosine
Other Intervention Name(s)
Videx
Intervention Description
400 mg taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Other Intervention Name(s)
Sustiva
Intervention Description
600 mg taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Emtricitabine/Tenofovir disoproxil fumarate
Other Intervention Name(s)
Truvada
Intervention Description
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
Epivir, 3TC
Intervention Description
300 mg taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Other Intervention Name(s)
Kaletra
Intervention Description
200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Other Intervention Name(s)
Viramune, NVP
Intervention Description
200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Intervention Type
Drug
Intervention Name(s)
Stavudine
Other Intervention Name(s)
Zerit, d4T
Intervention Description
Dosage depends on weight
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate
Other Intervention Name(s)
Viread, TDF
Intervention Description
300 mg taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Zidovudine/Lamivudine
Other Intervention Name(s)
Combivir
Intervention Description
150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Primary Outcome Measure Information:
Title
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Description
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.
Time Frame
Throughout study
Title
All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Description
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.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for HIV Infected Partner:
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
Inclusion Criteria for HIV Uninfected Partner:
Negative HIV test within 14 days of study entry
Inclusion Criteria for Both Partners:
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
Exclusion Criteria for HIV Infected Partner:
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
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
Exclusion Criteria for Both Partners:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron S. Cohen, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
Facility Information:
Facility Name
Fenway Community Health Ctr. CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Gaborone CRS
City
Gaborone
Country
Botswana
Facility Name
Hospital Geral de Nova Iguaçu CRS (HGNI CRS)
City
Nova Iguacu
State/Province
Rio De Janeiro
ZIP/Postal Code
26030-380
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao CRS
City
Port Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350 200
Country
Brazil
Facility Name
HSE-Hospital dos Servidores do Estado CRS
City
Rio de Janeiro
ZIP/Postal Code
20221-903
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411002
Country
India
Facility Name
NARI Clinic at NIV CRS
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
NARI Pune CRS
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411026
Country
India
Facility Name
Chennai Antiviral Research and Treatment (CART) CRS
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600113
Country
India
Facility Name
Kisumu Crs
City
Kisumu
State/Province
Nyanza
ZIP/Postal Code
40100
Country
Kenya
Facility Name
Blantyre CRS
City
Blantyre
Country
Malawi
Facility Name
Malawi CRS
City
Lilongwe
Country
Malawi
Facility Name
Soweto HPTN CRS
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2092
Country
South Africa
Facility Name
CMU HIV Prevention CRS
City
Chiang Mai
ZIP/Postal Code
50202
Country
Thailand
Facility Name
Parirenyatwa CRS
City
Harare
Country
Zimbabwe
12. IPD Sharing Statement
Citations:
PubMed Identifier
17059632
Citation
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.
Results Reference
background
PubMed Identifier
16022655
Citation
Chan 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.
Results Reference
background
PubMed Identifier
15078894
Citation
Davis 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.
Results Reference
background
PubMed Identifier
16492075
Citation
Gupta 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.
Results Reference
background
PubMed Identifier
30157702
Citation
Odero 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.
Results Reference
derived
PubMed Identifier
27424812
Citation
Cohen 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.
Results Reference
derived
PubMed Identifier
24602844
Citation
Grinsztejn 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. Erratum In: Lancet Infect Dis. 2014 Apr;14(4):269.
Results Reference
derived
PubMed Identifier
21767103
Citation
Cohen 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.
Results Reference
derived
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Preventing Sexual Transmission of HIV With Anti-HIV Drugs
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