NCT01810315

Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity

Influence of Female Reproductive Cycle and Menopause on Cervicovaginal Tissue Susceptibility to HIV-1 Infections and Tenofovir 1% Gel Activity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 21 Years – 89 Years
• Healthy volunteers: Accepted

Summary

Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator use in premenopausal and postmenopausal women.

Detailed description

Premenopausal women: Baseline blood and genital samples will be taken in the follicular and luteal phase (visits 2 and 3). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visits 4/4a and 5/5a). Postmenopausal women: Premenopausal women: Baseline blood and genital samples will be taken (visit 2). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visit 3/3a). Estradiol cream will be distributed at visit 4. Post estradiol blood and genital samples will be taken at Visit 5. The participant will given TFV gel and instructed to insert 2 doses as before, while continuing to use the estradiol cream. Post TFV gel and estradiol cream blood and genital samples will be taken (visit 6/6a).

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DRUG	TFV 1% gel
DRUG	Estradiol vaginal cream

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-03-13
• Last updated: 2015-04-10

Locations

1 site across 1 country: United States