Status:
COMPLETED
HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.
Lead Sponsor:
University of Washington
Collaborating Sponsors:
GlaxoSmithKline
Asociación Civil Impacta Salud y Educación, Peru
Conditions:
HIV Infection
Herpes Simplex
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that ...
Detailed Description
Herpes simplex virus type 2 (HSV-2) is common among HIV infected persons. HSV-2 reactivation is associated with increased plasma and genital HIV-1 levels, and in vitro, HSV-2 upregulates HIV transcrip...
Eligibility Criteria
Inclusion
- Greater than 18 years old,
- Documented HIV-1 seropositive,
- CD4 count greater than 200,
- Not on HIV antiretroviral therapy,
- HSV-2 seropositive as determined by Focus EIA (IN \>3.5)
- Not intending to move out of the area for the duration of study participation.
- Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.
- Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment.
Exclusion
- MSM who meet any of the following criteria are not eligible for this study:
- Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;
- Planned open label use of acyclovir, valacyclovir, or famciclovir
- Known medical history of seizures
- Known renal failure, serum creatinine \>2.0mg/dl
- Hematocrit \< 30 %
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00378976
Start Date
August 1 2003
End Date
July 1 2004
Last Update
August 22 2013
Active Locations (1)
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1
Asociacion Civil Impacta Salud y Educacion
Lima, Peru