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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Microbicide Trials Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00592124 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tenofovir disoproxil fumarate Drug: Tenofovir gel |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir |
Estimated Enrollment: | 144 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Oral tenofovir disproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
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Drug: Tenofovir disoproxil fumarate
300 mg tablet daily
Drug: Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
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2: Experimental
Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
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Drug: Tenofovir disoproxil fumarate
300 mg tablet daily
Drug: Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
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3: Experimental
Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
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Drug: Tenofovir disoproxil fumarate
300 mg tablet daily
Drug: Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
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4: Experimental
Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
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Drug: Tenofovir disoproxil fumarate
300 mg tablet daily
Drug: Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
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5: Experimental
Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
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Drug: Tenofovir disoproxil fumarate
300 mg tablet daily
Drug: Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
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6: Experimental
Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
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Drug: Tenofovir disoproxil fumarate
300 mg tablet daily
Drug: Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
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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. 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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Alabama Microbicide CRS | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Hala Fawal, MBA, MPH 205-975-8699 hfawal@uab.edu | |
Principal Investigator: Craig Hoesley, MD | |
United States, Ohio | |
Case CRS | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Jane Baum, RN 216-844-8786 MXL6@case.edu | |
Principal Investigator: Michael M. Lederman, MD | |
United States, Pennsylvania | |
Pitt CRS | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15213-2582 | |
Contact: Christine A. Tripoli, BSN, RN 412-647-0771 tripolica@upmc.edu | |
Principal Investigator: Sharon A. Riddler, MD |
Study Chair: | Craig W. Hendrix, MD | Johns Hopkins University |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | MTN-001, 1-U01-AI068633-01 |
Study First Received: | December 31, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00592124 |
Health Authority: | United States: Food and Drug Administration |
Microbicide HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |