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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 regimen

Proportion 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 missed

Frequency 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

Page last updated: August 23, 2015

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