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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
Est. primary completion date
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


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
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