Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed

Phase 3

Phase 2

Conditions

HIV Infections

HIV-1 and HSV-2 Coinfection

Treatments

Drug: Acyclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT00209313

IR File 5687

AI 30731 (Project 1)

Details and patient eligibility

About

The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.

Full description

The main objective is to assess the reduction in genital HIV-1 shedding associated with daily acyclovir for suppression of HSV-2 reactivation.

All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study. In addition, half will receive acyclovir for 8 weeks , whilst the other half will receive a placebo for 8 weeks. The study medication will reverse in the second 8 weeks of the study. The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant. At each visit genital and oral samples will be collected. A blood sample will also be collected. For women participants, pregnancy test will be performed. The clinic will provide both pre- and post-HIV test counseling.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years old and above
Documented HIV-seropositive
HSV-2 seropositive as determined by Focus EIA
Not intending to move out of the area for the duration of study participation
Willing and able to:
1. provide independent written informed consent
2. undergo clinical evaluations
3. take study drug as directed
4. adhere to follow-up schedule
Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea, chlamydia, syphilis) are treated within two weeks if study enrollment and random assignment.

Exclusion criteria

Women who meet any of the following criteria are not eligible for this study.
1. Known history of adverse reaction to acyclovir
2. Planned open label use of acyclovir, valacyclovir, or famciclovir
3. Positive pregnancy test
4. Active opportunistic infection