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A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes.

CLINICAL TRIAL, RANDOMIZED, DOUBLE-BLIND, CONTROLLED AGAINST PLACEBO USING ACICLOVIR FOR THE REDUCTION OF THE ACQUISITION OF INFECTION WITH THE HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN INDIVIDUALS SEROPOSITIVES TO SIMPLE TYPE 2 HERPES VIRUSES AND HIV SERONEGATIVES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-081-02
Enrollment
179
Registered
2002-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

ACICLOVIR Type of group
Acyclovir 400 mg orally twice a day. Group name:Placebo Type of group
Placebo orally twice a day for 12 or 18 months tracing.

Sponsors

FAMILY HEALTH INTERNATIONAL, HPTN CORE,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: HIV-uninfected HSV-2 infected Plans to stay in the area for the duration of study participation Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information

Exclusion criteria

Exclusion criteria: Current enrollment in another HIV vaccine or prevention trial History of adverse reaction to acyclovir Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed. Known plans for travel away from study site for more than 2 months

Design outcomes

Primary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru, South Africa, United States, Zambia, Zimbabwe

Outcome results

None listed

Source: REPEC (via WHO ICTRP)