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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CONRAD
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria: All volunteers

• In good healthsignificant systemic disease

• Not at risk of an STI, meaning: In a monogamous heterosexual or same sex relationship for at least the last four months with a partner who is not known to be HIV positive and has no known risks for STIs OR sexually abstinent

• Willing and able to comply with study procedures

• Normal Pap smear (by written report) in the past year.

Inclusion Criteria: Premenopausal volunteers

• 21-to-45 years of age

• Not at risk for pregnancy, meaning:

• Regular menstrual cycles (every 24 - 35 days)

• Luteal phase P level of greater than or equal to 3 ng/ml

Inclusion Criteria: Postmenopausal volunteers

• 46-89 years of age OR both ovaries removed at least 30 days prior to Visit 1

• No menstrual periods/vaginal bleeding in the past 12 months OR both ovaries removed at least 30 days prior to Visit 1

• FSH level of greater than or equal to 20 MIU/ml

Exclusion Criteria: All volunteers

• Clinically significant history of an abnormal Pap smear in the past year

• Surgery or biopsy of the vagina or cervix within 30 days

• Current STI or lower genital tract infection

• Current use of chronic immunosuppressants

• Current presence of vulvar, anal and/or vaginal genital warts

• Current tobacco use of any amount

• History of sensitivity/allergy to any component of the study product, topical anesthetic, or allergy to silver nitrate and/or Monsel's solution

• Known bleeding disorder that could lead to prolonged or continuous bleeding

• Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS Table for Grading the Severity of Adverse Events

• Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals, antivirals or antiretrovirals.

• Investigator discretion

• Current participation in any other drug or device study

Exclusion Criteria: Premenopausal women

• Use of DMPA in last six months

• Use of any other hormonal contraceptive method without 2 subsequent, normal menses since stopping hormonal contraceptives

• Current use of copper IUD

• Currently pregnant or pregnancy within the past 3 months

• Currently breastfeeding/having breastfed an infant in the last 2 months

Exclusion Criteria: Postmenopausal women

• Use of any hormonal medications in the past 30 days

• Contraindications to vaginal estrogen cream