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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV-1 and HSV-2 Coinfection
• Intervention / Treatment: Drug: Acyclovir

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Cameroon
  • Yaounde, Cameroon
    • Hospital Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo	Drug: Acyclovir; Acyclovir 800 mg twice daily or placebo
Other: 2; 8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily	Drug: Acyclovir; Acyclovir 800 mg twice daily or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HSV and HIV viral shedding	18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
HSV suppression and HIV shedding	18 weeks

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: Institute for the Development of Africa
• Investigators: Principal Investigator: Francois-Xavier Mbopi-Keou, M.Sc, PhD, Institute for the Development of Africa

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: HIV-1; Africa; Coinfection; Cameroon; HSV-2
• Additional Relevant MeSH Terms: Infections; Coinfection; Anti-Infective Agents; Antiviral Agents; Acyclovir
• Other Study ID Numbers: IR File 5687; AI 30731 (Project 1)