Clinical trial NCT00362596: A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Official title: A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Herpes
Keywords: Acyclovir
HIV
HSV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Ministry of Health, Thailand
First posted: 2006-08-10
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 criteria: Inclusion Criteria:

* participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

* pregnancy, CD4 count \<200, on ART

Primary outcomes:
measure: To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
Secondary outcomes:
measure: To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
measure: To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
measure: To evaluate the association of genital symptoms and HIV or HSV genital shedding.
measure: To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.
Other outcomes:
Locations:
city: Chiang Rai
country: Thailand
facility: TUC
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Eileen F. Dunne, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Sara Whitehead, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunne EF, Whitehead S, Sternberg M, Thepamnuay S, Leelawiwat W, McNicholl JM, Sumanapun S, Tappero JW, Siriprapasiri T, Markowitz L. Suppressive acyclovir therapy reduces HIV cervicovaginal shedding in HIV- and HSV-2-infected women, Chiang Rai, Thailand. J Acquir Immune Defic Syndr. 2008 Sep 1;49(1):77-83. doi: 10.1097/QAI.0b013e3181831832.