Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
NCT ID: NCT00592124
Last Updated: 2021-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2008-06-30
2010-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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1
Oral tenofovir disoproxil 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
Tenofovir disoproxil fumarate
300 mg tablet daily
Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
2
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
Tenofovir disoproxil fumarate
300 mg tablet daily
Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
3
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
Tenofovir disoproxil fumarate
300 mg tablet daily
Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
4
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
Tenofovir disoproxil fumarate
300 mg tablet daily
Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
5
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
Tenofovir disoproxil fumarate
300 mg tablet daily
Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
6
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
Tenofovir disoproxil fumarate
300 mg tablet daily
Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
Interventions
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Tenofovir disoproxil fumarate
300 mg tablet daily
Tenofovir gel
1 gm/100 ml of 1% gel vaginally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Microbicide Trials Network
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Craig W. Hendrix, MD
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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Alabama Microbicide CRS
Birmingham, Alabama, United States
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)
The Bronx, New York, United States
Case CRS
Cleveland, Ohio, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
Botha's Hill CRS
Durban, KwaZulu-Natal, South Africa
Umkomaas CRS
Durban, KwaZulu-Natal, South Africa
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, , Uganda
Countries
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References
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Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. No abstract available.
Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse 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. doi: 10.1097/01.aids.0000210608.70762.c3.
Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus NN. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One. 2013;8(1):e55013. doi: 10.1371/journal.pone.0055013. Epub 2013 Jan 30.
Minnis AM, van der Straten A, Salee P, Hendrix CW. Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions. AIDS Behav. 2016 Jul;20(7):1541-8. doi: 10.1007/s10461-015-1081-3.
Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, Nakabiito C, Hoesley C, Justman J, Soto-Torres L, Patterson K, Gomez K, Hendrix CW. Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav. 2013 Feb;17(2):737-47. doi: 10.1007/s10461-012-0333-8.
Other Identifiers
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10617
Identifier Type: REGISTRY
Identifier Source: secondary_id
MTN-001
Identifier Type: -
Identifier Source: org_study_id