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A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; Herpes

Intervention: acyclovir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Centers for Disease Control and Prevention

Official(s) and/or principal investigator(s):
Eileen F. Dunne, MD, MPH, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
Sara Whitehead, MD, MPH, Principal Investigator, Affiliation: Centers for Disease Control and Prevention

Summary

Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission. Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes Simplex Virus Type-2 (HSV-2) in Thailand.

Clinical Details

Official title: A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.

Secondary outcome:

To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.

To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.

To evaluate the association of genital symptoms and HIV or HSV genital shedding.

To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.

Detailed description: 65 women ages 18-49 years old with HIV-1 and HSV-2 co-infection are being recruited from general medicine clinics, family planning clinics, postnatal clinics, community based organizations and community outreach in Chiang Rai, Thailand. Our study objectives are:

- To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.

- To determine the association between HIV and HSV genital shedding, and the effect of

acyclovir suppressive therapy on this association.

- To determine the acceptability of acyclovir suppressive therapy for women with HIV

infection.

- To evaluate the association of genital symptoms and HIV or HSV genital shedding.

- To evaluate the association between cervicovaginal (CVL) specimens and self-collected

genital swabs for detection of HIV and HSV-2.

Eligibility

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

- pregnancy, CD4 count <200, on ART

Locations and Contacts

TUC, Chiang Rai, Thailand
Additional Information

Starting date: January 2005
Last updated: August 9, 2006

Page last updated: August 23, 2015

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