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

This study has been completed.
Sponsor:
Collaborator:
Institute for the Development of Africa
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00209313
First received: September 13, 2005
Last updated: December 14, 2011
Last verified: December 2011

September 13, 2005
December 14, 2011
March 2005
Not Provided
HSV and HIV viral shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
HSV and HIV viral shedding in 18 weeks
Complete list of historical versions of study NCT00209313 on ClinicalTrials.gov Archive Site
HSV suppression and HIV shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
HSV suppression and HIV shedding in 18 weeks
Not Provided
Not Provided
 
Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • HIV-1 and HSV-2 Coinfection
  • HIV Infections
Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo
  • 1
    Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
    Intervention: Drug: Acyclovir
  • 2
    8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily
    Intervention: Drug: Acyclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2007
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT00209313
IR File 5687, AI 30731 (Project 1)
No
Anna Wald, MD, MPH, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Institute for the Development of Africa
Principal Investigator: Francois-Xavier Mbopi-Keou, M.Sc, PhD Institute for the Development of Africa
Fred Hutchinson Cancer Research Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP