Official Title: “A Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Acyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons in Cameroon”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Acyclovir
  • Acyclovir 800 mg twice daily or placebo

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
• Other: 2
  • 8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily

Primary Measures

• HSV and HIV viral shedding
  • Time Frame: 18 weeks
    Safety Issue?: No

Secondary Measures

• HSV suppression and HIV shedding
  • Time Frame: 18 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Fred Hutchinson Cancer Research Center

Overall Clinical Trial Officials and Contacts

Francois-Xavier Mbopi-Keou, M.Sc, PhD Principal Investigator Institute for the Development of Africa  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209313

Study ID Number: IR File 5687

ClinicalTrials.gov Identifier: NCT00209313

Health Authority: United States: Institutional Review Board