Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194519
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2005-09-13
Brief Title:
Herpes Simplex Virus Type 2 HSV-2 Suppression to Prevent HIV Transmission
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hisher HIV negative partners 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 411 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
Under the study protocol version 411 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
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 21 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 HIVHSV-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 KitweNdola and Lusaka Zambia Nairobi Kisumu Eldoret and Thika Kenya Moshi Tanzania Kampala Uganda and Kigali Rwanda
This trial will directly answer the extent to which HSV-2 infection increases infectiousness of HIVHSV-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 KitweNdola and Lusaka Zambia Nairobi Kisumu Eldoret and Thika Kenya Moshi Tanzania Kampala Uganda and Kigali Rwanda
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Gates Foundation Grant 26469 | None | None | None |