Dataset Information

Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.

ABSTRACT: The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and >500 relative to <350, respectively, p<0.001).The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission.ClinicalTrials.gov NCT00194519.

SUBMITTER: Lingappa JR

PROVIDER: S-EPMC2671170 | biostudies-literature | 2009

REPOSITORIES: biostudies-literature

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Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.

Lingappa Jairam R JR Kahle Erin E Mugo Nelly N Mujugira Andrew A Magaret Amalia A Baeten Jared J Bukusi Elizabeth A EA Cohen Craig R CR Katabira Elly E Ronald Allan A Kiarie James J Farquhar Carey C Stewart Grace John GJ Makhema Joseph J Essex M M Were Edwin E Fife Kenneth K Debruyn Guy G Gray Glenda G McIntyre James J Manongi Rachel R Kapiga Saidi S Coetzee David D Allen Susan S Inambao Mubiana M Kayitenkore Kayitesi K Karita Etienne E Kanweka William W Delany Sinead S Rees Helen H Vwalika Bellington B Coombs Robert W RW Morrow Rhoda R Whittington William W Corey Lawrence L Wald Anna A Celum Connie C

PloS one 20090430 4

<h4>Background</h4>The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.<h4>Methods</h4>HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected p ...[more]

PMID: 19404392

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Project description:BACKGROUND:Antiretroviral drugs have been shown to reduce risk of mother-to-child transmission of human immunodeficiency virus (HIV) and are also widely used for post-exposure prophylaxis for parenteral and sexual exposures. Sexual transmission may be lower in couples in which one partner is infected with HIV and the other is not and the infected partner is on antiretroviral therapy (ART). OBJECTIVES:To determine if ART use in an HIV-infected member of an HIV-discordant couple is associated with lower risk of HIV transmission to the uninfected partner compared to untreated discordant couples. SEARCH METHODS:We used standard Cochrane methods to search electronic databases and conference proceedings with relevant search terms without limits to language. SELECTION CRITERIA:Randomised controlled trials (RCT), cohort studies and case-control studies of HIV-discordant couples in which the HIV-infected member of the couple was being treated or not treated with ART DATA COLLECTION AND ANALYSIS: Abstracts of all trials identified by electronic or bibliographic scanning were examined independently by two authors. We initially identified 3,833 references and examined 87 in detail for study eligibility. Data were abstracted independently using a standardised abstraction form. MAIN RESULTS:One RCT and nine observational studies were included in the review. These ten studies identified 2,112 episodes of HIV transmission, 1,016 among treated couples and 1,096 among untreated couples. The rate ratio for the single randomised controlled trial was 0.04 [95% CI 0.00, 0.27]. All index partners in this study had CD4 cell counts at baseline of 350-550 cells/µL. Similarly, the summary rate ratio for the nine observational studies was 0.58 [95% CI 0.35, 0.96], with substantial heterogeneity (I(2)=64%). After excluding two studies with inadequate person-time data, we estimated a summary rate ratio of 0.36 [95% CI 0.17, 0.75] with substantial heterogeneity (I(2)=62%). We also performed subgroup analyses among the observational studies to see if the effect of ART on prevention of HIV differed by the index partner's CD4 cell count. Among couples in which the infected partner had ?350 CD4 cells/µL, we estimated a rate ratio of 0.12 [95% CI 0.01, 1.99]. In this subgroup, there were 247 transmissions in untreated couples and 30 in treated couples. AUTHORS' CONCLUSIONS:ART is a potent intervention for prevention of HIV in discordant couples in which the index partner has ?550 CD4 cells/µL. A recent multicentre RCT confirms the suspected benefit seen in earlier observational studies and reported in more recent ones. Questions remain about durability of protection, the balance of benefits and adverse events associated with earlier therapy, long-term adherence and transmission of ART-resistant strains to partners. Resource limitations and implementation challenges must also be addressed.Counselling, support, and follow up, as well as mutual disclosure, may have a role in supporting adherence, so programmes should be designed with these components. In addition to ART provision, the operational aspects of delivering such programmes must be considered.

Project description:BackgroundIn HIV discordant couples (one parther is HIV-infected, another is HIV-uninfected) HIV-negative partners often remain uninfected for a long time despite long, stable, often unprotected sexual contacts with HIV-infected partner. The increase of time of living together accompanying the decrease of the incidence of HIV infection in HIV-negative partner. The features of HIV-specific immune response in HIV discorgant couples was investigated.MethodsThirty-three HIV discordant couples from Moscow region living together <1 year (2 couples), 1 to 3 years (18 couples), 4 to 5 years (9 couples), 6 to 10 years (4 couples) were included in the investigation. Sera of 33 HIV-uninfected partners from HIV discordant couples (17 men and 16 women) were tested for HIV-specific antibodies by enzyme immunoassay and immunoblot. Viral load was estimated by polymerase chain reaction (PCR).ResultsAntibodies against HIV gp160 were detected in 3 persons (9,1%), against p68/66—in 3 persons (9,1%), against p52/51—in 3 persons (9,1%), against g34/31—in 3 persons (9,1%); total—in 6 persons (18,2%). All of them were defined as HIV-uninfected by PCR. In 4 of 6 persons HIV-specific antibodies were not detected after finishing of risk behavior.ConclusionsIt is possible to suggest that detected antibodies against HIV gp160, p68/66, p52/51, p34/31 in HIV-uninfected people are caused by contact with HIV (according to literature data, non-specific stimulation may cause the appearance of antibodies binding the other HIV antigens: p55, p24/25 and g18) and may contribute to maintainance of HIV-negative status of uninfected partners in HIV-discordant couples. The cohort of high exposed but HIV-uninfected people was formed during immunological monitoring of HIV discordant couples in Moscow region. This cohort is available for systematic observation and is perspective for further investigation of mechanisms of resistance to HIV infection and correlates of immune protection. Now the cohort is expanded.

Dataset Information

Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.

Publications

Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.

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