Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission
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ClinicalTrials.gov Identifier: NCT00194519 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : October 12, 2018
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | September 13, 2005 | |||||||||
First Posted Date ICMJE | September 19, 2005 | |||||||||
Last Update Posted Date | October 12, 2018 | |||||||||
Study Start Date ICMJE | November 2004 | |||||||||
Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Sequence-verified HIV-transmission from index to partner participant [ Time Frame: March 2009 ] | |||||||||
Original Primary Outcome Measures ICMJE |
Sequence-verified HIV-transmission from index to partner participant | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission | |||||||||
Official Title ICMJE | Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples | |||||||||
Brief Summary | The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 >250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive. Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count >250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed. The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date. |
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Detailed Description | Herpes simplex virus type-2 (HSV-2) is the primary cause of genital ulcers and one of the most prevalent sexually transmitted diseases worldwide. Consistently, over 30 studies have found HSV-2 infection to be a risk factor for HIV acquisition with an overall relative risk of 2.1 in the studies that demonstrated HSV-2 preceded HIV infection. A recent study of HIV-discordant couples from Rakai, Uganda, has shown that at all levels of HIV viral load in the HIV-positive partner, HSV-2 infection in the susceptible partner increased the per-contact risk of acquisition of HIV five-fold, and GUD in the HIV-source partner increased the per-contact risk of HIV transmission five-fold. As strong as these epidemiological data are, an intervention trial is required to define the clinical and public health significance of these findings. This trial will directly answer the extent to which HSV-2 infection increases infectiousness of HIV/HSV-2 co-infected persons and the relative reduction in HIV transmission among HSV-2 seropositive persons treated with daily suppressive antiviral therapy. Acyclovir has an acceptable safety profile for widespread STD treatment and is inexpensive, well-tolerated, and episodic and long-term suppressive therapy has not been associated with increased acyclovir resistance. Given high HSV-2 seroprevalence in HIV-infected persons (70-80%) and high HIV incidence in populations with high prevalence of HSV-2 infection worldwide, this approach could have great public health importance by providing a safe, acceptable, and cost-effective method to reduce HIV transmission among HIV-infected persons who are also HSV-2 seropositive. Sites that have enrolled couples in this study include: Johannesburg (2 sites) and Cape Town, South Africa; Gaborone, Botswana; Kitwe/Ndola and Lusaka, Zambia; Nairobi, Kisumu, Eldoret and Thika, Kenya; Moshi, Tanzania; Kampala, Uganda; and Kigali, Rwanda. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 3 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
3408 | |||||||||
Original Enrollment ICMJE |
3646 | |||||||||
Actual Study Completion Date ICMJE | March 2010 | |||||||||
Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Potential index (HIV-infected) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:
Potential partner (HIV-uninfected at enrollment) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:
Exclusion Criteria: Potential index (HIV-infected) participants who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:
Potential partner participants who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda, Zambia | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00194519 | |||||||||
Other Study ID Numbers ICMJE | STUDY00000867 Gates Foundation Grant #26469 |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Current Responsible Party | Connie Celum, University of Washington | |||||||||
Original Responsible Party | Not Provided | |||||||||
Current Study Sponsor ICMJE | University of Washington | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE | Bill and Melinda Gates Foundation | |||||||||
Investigators ICMJE |
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PRS Account | University of Washington | |||||||||
Verification Date | October 2018 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |