Clinical trial NCT00209313: Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV-1 and HSV-2 Coinfection
HIV Infections
Keywords: HIV-1
HSV-2
Coinfection
Africa
Cameroon
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Institute for the Development of Africa
First posted: 2005-09-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: HSV and HIV viral shedding
timeFrame: 18 weeks
Secondary outcomes:
measure: HSV suppression and HIV shedding
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Hospital Central
Study officials:
affiliation: Institute for the Development of Africa
name: Francois-Xavier Mbopi-Keou, M.Sc, PhD
role: PRINCIPAL_INVESTIGATOR
References: