Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
Information source: Fred Hutchinson Cancer Research Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-1 and HSV-2 Coinfection; HIV Infections
Intervention: Acyclovir (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s):
Francois-Xavier Mbopi-Keou, M.Sc, PhD, Principal Investigator, Affiliation: Institute for the Development of Africa
Summary
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.
Clinical Details
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
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: HSV and HIV viral shedding
Secondary outcome: HSV suppression and HIV shedding
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Hospital Central, Yaounde, Cameroon
Additional Information
Starting date: March 2005
Ending date: September 2008
Last updated: December 20, 2007
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