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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23507
- Clinical Research Center, Eastern Virginia Medical School
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Baseline
Premenopausal women will undergo baseline sampling in each the follicular and luteal phase.
Postmenopausal women will undergo baseline sampling one time.
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Experimenteel: TFV 1% Gel
Participants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later. Each applicator contains 4.4 gm of TFV 1% gel. Premenopausal women will undergo sampling after TFV gel use in each the follicular and luteal phase. Postmenopausal women will undergo sampling after TFV gel use one time. |
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Experimenteel: Estradiol Vaginal Cream
Post menopausal women only: Participants will insert 2 grams of estradiol cream into the vagina every night for 14 days and then one gram of estradiol cream into the vagina every other night
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Experimenteel: TFV 1% gel and estradiol cream
Postmenopausal women only: Participants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later.
Each applicator contains 4.4 gm of TFV 1% gel.
In addition, participants will one gram of estradiol cream into the vagina every other night.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Concentrations of tenofovir in plasma, vaginal aspirate, and genital tissue
Tijdsspanne: 3 hours after dosing
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3 hours after dosing
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Concentrations of TFV-DP in genital tissue
Tijdsspanne: 3 hours after dosing
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3 hours after dosing
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A12-124
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