Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Tenofovir disoproxil fumarate (Drug); Tenofovir gel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Craig W. Hendrix, MD, Study Chair, Affiliation: Johns Hopkins University
Summary
A new approach to HIV prevention currently being studied includes the use of microbicides,
substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved,
anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study
is to determine the adherence and acceptability to and blood levels of three daily regimens
of tenofovir in both oral and gel form.
Clinical Details
Official title: Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Self-reported adherence to each regimenProportion of participants who indicate they would be "unlikely" use study product in the future Area under the concentration-time curve (AUC), maximum serum concentrations (Cmax), and minimum serum concentrations (Cmin) during PK studies
Secondary outcome: Proportion of women who report taking at least 90% of expected daily doses, frequency of use, and number of days product missedFrequency of sexual activity and male condom use Time interval between product usage and sexual intercourse and sequence of product use and sexual intercourse Reported sharing and quantity of study product Grade 3 or higher toxicity for systemic and local effects as defined by the protocol
Detailed description:
It is necessary to monitor both the adherence and blood levels of microbicides in order to
gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir
gel) and an anti-HIV drug (TDF), this study will measure the adherence and acceptability to
and blood levels of the two interventions in three separate regimens given to HIV-uninfected
women.
The expected duration of participation for each participant is 21 weeks. Study participants
will be randomly assigned into one of six study groups, each with a different regimen
sequence. Each sequence will consist of three study periods and three wash-out periods. Each
study period lasts 6 weeks, followed by a 1 week wash-out period. The regimen assigned for a
given study period will include either oral TDF, tenofovir vaginal gel, or both. All
participants will be prescribed all three regimens in the order designated by their
randomized assignment.
Study visits will occur at Weeks 1, 3, 6, 7, 10, 13, 14, 17, 20, and 21. Medical history, a
physical exam, behavioral assessment, and urine, blood, pelvic sample collection, and
counseling will occur at all visits. At some study sites rectal swabs may be performed.
Counseling will include information regarding contraception, protocol adherence, HIV,
HIV/Sexually Transmitted Infection risk reduction, and male condom use. Pharmacokinetic (PK)
studies, to be determined by the study site, will occur during all three study periods.
These studies may involve additional procedures.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- General good health
- HIV-uninfected
- Normal menstrual cycle. More information can be found in the protocol.
- Creatinine clearance greater than 70 ml/min
- Sexually active. More information can be found in the protocol.
- Normal Pap smear result within 12 months prior to study entry
- Agrees to not participate in other investigational studies
- Willing to use effective forms of contraception. More information can be found in the
protocol.
Exclusion Criteria:
- Adverse reaction to either of the study products
- Adverse reaction to latex
- Currently sexually active with a partner with history of adverse reaction to latex
- More than three sexual partners in the month prior to screening
- Pathologic bone fracture not related to trauma
- Last pregnancy outcome within 90 days or less prior to enrollment
- Gynecologic or genital procedure within 90 days of study entry
- Enrollment in other investigational study within 30 days of study entry
- Nontherapeutic injection drug use within 12 months of screening
- Any social or medical condition that, in the opinion of the investigator, would
interfere with the study
- Abnormal laboratory values
- Grade 2 or higher genital lesions, erythema, and/or edema or has any other abnormal
physical or pelvic exam finding that, in the opinion of the investigator, would
interfere with the study
- Kidney, reproductive, or urinary tract infection requiring treatment. More
information on this criterion can be found in the protocol.
- Pregnant, breastfeeding, or intend to become pregnant
- Unwilling to comply with study participation requirements, including attendance at
all scheduled study visits
- Per participant report, use of the following at enrollment, and/or anticipated use
during the period of study participation - use of a diaphragm, vaginal ring, and/or
spermicide for contraception, acyclovir or valacyclovir, post-exposure prophylaxis
for HIV exposure, TDF/emtricitabine, non-study vaginal products
Locations and Contacts
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS, Kampala, Uganda
Alabama Microbicide CRS, Birmingham, Alabama 35294, United States
Botha's Hill CRS, Durban, KwaZulu-Natal, South Africa
Umkomaas CRS, Durban, KwaZulu-Natal, South Africa
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS), Bronx, New York, United States
Case CRS, Cleveland, Ohio 44106, United States
Pitt CRS, Pittsburgh, Pennsylvania 15213-2582, United States
Additional Information
Click here for more information on tenofovir Click here for more information about tenofovir disoproxil fumarate Click here for the Microbicide Trials Network Web site
Related publications: Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. Review. Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Mâsse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51.
Starting date: June 2008
Last updated: June 24, 2013
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