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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: January 4, 2017
Last verified: January 2017
Results First Received: January 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Drug: Tenofovir disoproxil fumarate
Drug: Tenofovir gel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants in this study were selected from a total of 7 multinational clinical research sites, with first enrollment taking place on 4 March 2009 and last on 3 February 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
O, V, OV

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

V, O, OV

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

OV, O, V

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

OV, V, O

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

O, OV, V

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

V, OV, O

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


Participant Flow:   Overall Study
    O, V, OV   V, O, OV   OV, O, V   OV, V, O   O, OV, V   V, OV, O
STARTED   28   29   30   27   27   27 
COMPLETED   24   24   24   24   24   24 
NOT COMPLETED   4   5   6   3   3   3 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline population consists of evaluable enrolled participants.

Reporting Groups
  Description
O, V, OV

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

V, O, OV

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

OV, O, V

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

OV, V, O

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

O, OV, V

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

V, OV, O

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

Total Total of all reporting groups

Baseline Measures
   O, V, OV   V, O, OV   OV, O, V   OV, V, O   O, OV, V   V, OV, O   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
Age 
[Units: Years]
Mean (Standard Deviation)
             
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
   32.3  (7.6)   29.1  (6.3)   29.8  (6.5)   31.3  (6.4)   31.1  (7.5)   31.3  (8.2)   30.8  (7.1) 
Gender 
[Units: Participants]
Count of Participants
             
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
Female      24 100.0%      24 100.0%      24 100.0%      24 100.0%      24 100.0%      24 100.0%      144 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
Hispanic or Latino      1   4.2%      2   8.3%      0   0.0%      2   8.3%      0   0.0%      1   4.2%      6   4.2% 
Not Hispanic or Latino      11  45.8%      10  41.7%      12  50.0%      10  41.7%      13  54.2%      11  45.8%      67  46.5% 
Unknown or Not Reported      12  50.0%      12  50.0%      12  50.0%      12  50.0%      11  45.8%      12  50.0%      71  49.3% 
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
             
Participants Analyzed 
[Units: Participants]
 12   12   12   12   12   12   72 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   8.3%      0   0.0%      1   1.4% 
Asian      0   0.0%      2  16.7%      0   0.0%      1   8.3%      0   0.0%      0   0.0%      3   4.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7  58.3%      4  33.3%      9  75.0%      4  33.3%      6  50.0%      5  41.7%      35  48.6% 
White      5  41.7%      6  50.0%      3  25.0%      6  50.0%      5  41.7%      7  58.3%      32  44.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      1   8.3%      0   0.0%      0   0.0%      1   1.4% 
[1] Race categories applicable to USA participants only.
Region of Enrollment 
[Units: Participants]
             
United States               
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
United States   12   12   12   12   12   12   72 
South Africa               
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
South Africa   8   8   8   8   8   8   48 
Uganda               
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
Uganda   4   4   4   4   4   4   24 
Are you currently married? 
[Units: Participants]
Count of Participants
             
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
Yes      9  37.5%      9  37.5%      8  33.3%      10  41.7%      9  37.5%      12  50.0%      57  39.6% 
No      15  62.5%      15  62.5%      16  66.7%      14  58.3%      15  62.5%      12  50.0%      87  60.4% 
Do you currently have a male sex partner? 
[Units: Participants]
Count of Participants
             
Yes               
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
Yes   15   15   16   13   14   12   85 
No               
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
No   9   9   8   11   10   12   59 
What is your household(s) average monthly income? [1] 
[Units: US Dollars]
Median (Inter-Quartile Range)
             
Participants Analyzed 
[Units: Participants]
 24   23   24   23   23   23   140 
   495.40 
 (227.00 to 1250.00) 
 773.01 
 (122.70 to 3200.00) 
 417.18 
 (141.75 to 940.80) 
 490.80 
 (147.24 to 2400.00) 
 368.10 
 (98.16 to 1500.00) 
 306.75 
 (98.16 to 2500.00) 
 495.40 
 (134.99 to 1900.00) 
[1] Four participants did not provide information on household income.
What is your highest education level? 
[Units: Participants]
Count of Participants
             
Participants Analyzed 
[Units: Participants]
 24   24   24   24   24   24   144 
No Schooling      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   4.2%      0   0.0%      1   0.7% 
Primary School, Not Complete      1   4.2%      3  12.5%      1   4.2%      2   8.3%      0   0.0%      1   4.2%      8   5.6% 
Primary School, Complete      0   0.0%      1   4.2%      2   8.3%      1   4.2%      1   4.2%      2   8.3%      7   4.9% 
Secondary School, Not Complete      7  29.2%      5  20.8%      4  16.7%      6  25.0%      7  29.2%      8  33.3%      37  25.7% 
Secondary School, Complete      8  33.3%      3  12.5%      6  25.0%      4  16.7%      6  25.0%      2   8.3%      29  20.1% 
Attended College or University      8  33.3%      12  50.0%      11  45.8%      11  45.8%      9  37.5%      11  45.8%      62  43.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-reported Adherence to Each Regimen   [ Time Frame: Measured through Week 21 ]

2.  Primary:   Proportion of Participants Who Indicate They Would be "Unlikely" Use Study Product in the Future   [ Time Frame: Measured through Week 21 ]

3.  Primary:   Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)   [ Time Frame: Measured through Week 21 ]

4.  Secondary:   Frequency of Product Use   [ Time Frame: Measured through Week 21 ]

5.  Secondary:   Number of Days Product Missed   [ Time Frame: Measured through Week 21 ]

6.  Secondary:   Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses   [ Time Frame: Measured through Week 21 ]

7.  Secondary:   Frequency of Sexual Activity   [ Time Frame: Measured through Week 21 ]

8.  Secondary:   Frequency of Male Condom Use   [ Time Frame: Measured through Week 21 ]

9.  Secondary:   Tablet Usage Before Sex   [ Time Frame: Measured through Week 21 ]

10.  Secondary:   Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.   [ Time Frame: Measured through Week 21 ]

11.  Secondary:   Tablet Usage After Sex   [ Time Frame: Measured through Week 21 ]

12.  Secondary:   Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.   [ Time Frame: Measured through Week 21 ]

13.  Secondary:   Gel Usage Before Sex   [ Time Frame: Measured through Week 21 ]

14.  Secondary:   Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.   [ Time Frame: Measured through Week 21 ]

15.  Secondary:   Gel Usage After Sex   [ Time Frame: Measured through Week 21 ]

16.  Secondary:   Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.   [ Time Frame: Measured through Week 21 ]

17.  Secondary:   Reported Sharing of Product   [ Time Frame: Measured through Week 21 ]

18.  Secondary:   Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol   [ Time Frame: Measured through Week 21 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
For a full discussion of the difficulties of sampling and comparing findings in the varied and complex anatomic spaces in this study, please see the primary publication: PLoS One 2013;8(1):e55013. PMCID:PMC3559346


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Craig W. Hendrix, MD
Organization: Johns Hopkins University
phone: 1 410 955-9707
e-mail: chendrix@jhmi.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00592124     History of Changes
Other Study ID Numbers: MTN-001
10617 ( Registry Identifier: DAIDS ES )
1U01AI068633-01 ( US NIH Grant/Contract Award Number )
Study First Received: December 31, 2007
Results First Received: January 4, 2017
Last Updated: January 4, 2017