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Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women

This study has been completed.
Sponsor:
Collaborator:
Microbicide Trials Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00592124
First received: December 31, 2007
Last updated: March 6, 2017
Last verified: January 2017
December 31, 2007
March 6, 2017
June 2008
July 2010   (Final data collection date for primary outcome measure)
  • Self-reported Adherence to Each Regimen [ Time Frame: Measured through Week 21 ]
    Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.
  • Proportion of Participants Who Indicate They Would be "Unlikely" Use Study Product in the Future [ Time Frame: Measured through Week 21 ]
  • Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) [ Time Frame: Measured through Week 21 ]
    PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.
  • Self-reported Adherence to Each Regimen [ Time Frame: Throughout study ]
  • Proportion of participants who indicate they would not use study product in the future [ Time Frame: Throughout study ]
  • Area under the concentration-time curve (AUC), maximum serum concentrations (Cmax), and minimum serum concentrations (Cmin) during PK studies [ Time Frame: Throughout study ]
Complete list of historical versions of study NCT00592124 on ClinicalTrials.gov Archive Site
  • Frequency of Product Use [ Time Frame: Measured through Week 21 ]
    This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period.
  • Number of Days Product Missed [ Time Frame: Measured through Week 21 ]
    This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product.
  • Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses [ Time Frame: Measured through Week 21 ]
  • Frequency of Sexual Activity [ Time Frame: Measured through Week 21 ]
    This represents the rate during the past 3 weeks at which participants engaged in vaginal sex.
  • Frequency of Male Condom Use [ Time Frame: Measured through Week 21 ]
  • Tablet Usage Before Sex [ Time Frame: Measured through Week 21 ]
    These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex.
  • Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet. [ Time Frame: Measured through Week 21 ]
    Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter).
  • Tablet Usage After Sex [ Time Frame: Measured through Week 21 ]
    These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex.
  • Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet. [ Time Frame: Measured through Week 21 ]
    Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter).
  • Gel Usage Before Sex [ Time Frame: Measured through Week 21 ]
    These summaries represent counts and percentages of participants using gel before last instance of vaginal sex.
  • Length of Time Vaginal Sexual Intercourse Took Place After Using Gel. [ Time Frame: Measured through Week 21 ]
    Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter).
  • Gel Usage After Sex [ Time Frame: Measured through Week 21 ]
    These summaries represent counts and percentages of participants using gel after last instance of vaginal sex.
  • Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel. [ Time Frame: Measured through Week 21 ]
    Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter).
  • Reported Sharing of Product [ Time Frame: Measured through Week 21 ]
    Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant.
  • Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol [ Time Frame: Measured through Week 21 ]
  • Proportion of women who report taking at least 90% of expected daily doses, frequency of use, and number of days product missed [ Time Frame: Throughout study ]
  • Frequency of sexual activity and male condom use [ Time Frame: Throughout study ]
  • Time interval between product usage and sexual intercourse and sequence of product use and sexual intercourse [ Time Frame: Throughout study ]
  • Reported sharing and quantity of study product [ Time Frame: Throughout study ]
  • Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol [ Time Frame: Throughout study ]
Not Provided
Not Provided
 
Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Prevention
HIV Infections
  • Drug: Tenofovir disoproxil fumarate
    300 mg tablet daily
    Other Name: TDF
  • Drug: Tenofovir gel
    1 gm/100 ml of 1% gel vaginally daily
    Other Names:
    • TFV
    • 9-[2-(Phosphonomethoxy)propyl]adenine
  • Experimental: 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
    Interventions:
    • Drug: Tenofovir disoproxil fumarate
    • Drug: Tenofovir gel
  • Experimental: 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
    Interventions:
    • Drug: Tenofovir disoproxil fumarate
    • Drug: Tenofovir gel
  • Experimental: 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
    Interventions:
    • Drug: Tenofovir disoproxil fumarate
    • Drug: Tenofovir gel
  • Experimental: 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
    Interventions:
    • Drug: Tenofovir disoproxil fumarate
    • Drug: Tenofovir gel
  • Experimental: 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
    Interventions:
    • Drug: Tenofovir disoproxil fumarate
    • Drug: Tenofovir gel
  • Experimental: 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
    Interventions:
    • Drug: Tenofovir disoproxil fumarate
    • Drug: Tenofovir gel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa,   Uganda,   United States
 
 
NCT00592124
MTN-001
10617 ( Registry Identifier: DAIDS ES )
1U01AI068633-01 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Microbicide Trials Network
Study Chair: Craig W. Hendrix, MD Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP