- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Virginia
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Norfolk, Virginia, États-Unis, 23507
- Clinical Research Center, Eastern Virginia Medical School
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: 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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Expérimental: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Concentrations of tenofovir in plasma, vaginal aspirate, and genital tissue
Délai: 3 hours after dosing
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3 hours after dosing
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Concentrations of TFV-DP in genital tissue
Délai: 3 hours after dosing
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3 hours after dosing
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A12-124
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