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
  Purpose

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.


Condition Intervention Phase
HIV-1 and HSV-2 Coinfection
HIV Infections
Drug: Acyclovir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • HSV and HIV viral shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HSV suppression and HIV shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2005
Study Completion Date: April 2007
Arms Assigned Interventions
1
Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo
2
8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily
Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209313

Locations
Cameroon
Hospital Central
Yaounde, Cameroon
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Institute for the Development of Africa
Investigators
Principal Investigator: Francois-Xavier Mbopi-Keou, M.Sc, PhD Institute for the Development of Africa
  More Information

No publications provided

Responsible Party: Anna Wald, MD, MPH, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00209313     History of Changes
Other Study ID Numbers: IR File 5687, AI 30731 (Project 1)
Study First Received: September 13, 2005
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
HIV-1
HSV-2
Coinfection
Africa
Cameroon

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Coinfection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Parasitic Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014