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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209313
• Other study ID #: IR File 5687
• Secondary ID: AI 30731 (Projec
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: December 14, 2011
• Start date: March 2005
• Est. completion date: April 2007

Study information

• Verified date: December 2011
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Coinfection
• HIV Infections
• HIV-1 and HSV-2 Coinfection

Intervention

Drug:
• Acyclovir
Acyclovir 800 mg twice daily or placebo

Locations

Country	Name	City	State
Cameroon	Hospital Central	Yaounde

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Institute for the Development of Africa

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HSV and HIV viral shedding		18 weeks	No
Secondary	HSV suppression and HIV shedding		18 weeks	No