Trial Outcomes & Findings for Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women (NCT NCT00592124)
NCT ID: NCT00592124
Last Updated: 2021-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Measured through Week 21
Results posted on
2021-10-19
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
30
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
3
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race categories applicable to USA participants only.
Baseline characteristics by cohort
| Measure |
O, V, OV
n=24 Participants
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
n=24 Participants
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
n=24 Participants
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
n=24 Participants
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
n=24 Participants
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
n=24 Participants
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
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 7.6 • n=24 Participants
|
29.1 years
STANDARD_DEVIATION 6.3 • n=24 Participants
|
29.8 years
STANDARD_DEVIATION 6.5 • n=24 Participants
|
31.3 years
STANDARD_DEVIATION 6.4 • n=24 Participants
|
31.1 years
STANDARD_DEVIATION 7.5 • n=24 Participants
|
31.3 years
STANDARD_DEVIATION 8.2 • n=24 Participants
|
30.8 years
STANDARD_DEVIATION 7.1 • n=144 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
144 Participants
n=144 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
67 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
71 Participants
n=144 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
1 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
1 Participants
n=72 Participants • Race categories applicable to USA participants only.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
2 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
1 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
3 Participants
n=72 Participants • Race categories applicable to USA participants only.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=72 Participants • Race categories applicable to USA participants only.
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
4 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
9 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
4 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
6 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
5 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
35 Participants
n=72 Participants • Race categories applicable to USA participants only.
|
|
Race (NIH/OMB)
White
|
5 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
6 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
3 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
6 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
5 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
7 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
32 Participants
n=72 Participants • Race categories applicable to USA participants only.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=72 Participants • Race categories applicable to USA participants only.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
1 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
0 Participants
n=12 Participants • Race categories applicable to USA participants only.
|
1 Participants
n=72 Participants • Race categories applicable to USA participants only.
|
|
Region of Enrollment
United States
|
12 participants
n=24 Participants
|
12 participants
n=24 Participants
|
12 participants
n=24 Participants
|
12 participants
n=24 Participants
|
12 participants
n=24 Participants
|
12 participants
n=24 Participants
|
72 participants
n=144 Participants
|
|
Region of Enrollment
South Africa
|
8 participants
n=24 Participants
|
8 participants
n=24 Participants
|
8 participants
n=24 Participants
|
8 participants
n=24 Participants
|
8 participants
n=24 Participants
|
8 participants
n=24 Participants
|
48 participants
n=144 Participants
|
|
Region of Enrollment
Uganda
|
4 participants
n=24 Participants
|
4 participants
n=24 Participants
|
4 participants
n=24 Participants
|
4 participants
n=24 Participants
|
4 participants
n=24 Participants
|
4 participants
n=24 Participants
|
24 participants
n=144 Participants
|
|
Are you currently married?
Yes
|
9 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
57 Participants
n=144 Participants
|
|
Are you currently married?
No
|
15 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
87 Participants
n=144 Participants
|
|
Do you currently have a male sex partner?
Yes
|
15 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
85 Participants
n=144 Participants
|
|
Do you currently have a male sex partner?
No
|
9 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
59 Participants
n=144 Participants
|
|
What is your household(s) average monthly income?
|
495.40 US Dollars
n=24 Participants • Four participants did not provide information on household income.
|
773.01 US Dollars
n=23 Participants • Four participants did not provide information on household income.
|
417.18 US Dollars
n=24 Participants • Four participants did not provide information on household income.
|
490.80 US Dollars
n=23 Participants • Four participants did not provide information on household income.
|
368.10 US Dollars
n=23 Participants • Four participants did not provide information on household income.
|
306.75 US Dollars
n=23 Participants • Four participants did not provide information on household income.
|
495.40 US Dollars
n=140 Participants • Four participants did not provide information on household income.
|
|
What is your highest education level?
No Schooling
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=144 Participants
|
|
What is your highest education level?
Primary School, Not Complete
|
1 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
8 Participants
n=144 Participants
|
|
What is your highest education level?
Primary School, Complete
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=144 Participants
|
|
What is your highest education level?
Secondary School, Not Complete
|
7 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
37 Participants
n=144 Participants
|
|
What is your highest education level?
Secondary School, Complete
|
8 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
29 Participants
n=144 Participants
|
|
What is your highest education level?
Attended College or University
|
8 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
62 Participants
n=144 Participants
|
PRIMARY outcome
Timeframe: Measured through Week 21Population: For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of expected doses if she were fully adherent.
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.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=144 Participants
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=144 Participants
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=144 Participants
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Self-reported Adherence to Each Regimen
|
94 percentage of expected doses
Standard Deviation 10.8
|
93.8 percentage of expected doses
Standard Deviation 10.2
|
93.9 percentage of expected doses
Standard Deviation 10.1
|
PRIMARY outcome
Timeframe: Measured through Week 21Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=141 Participants
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=139 Participants
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=142 Participants
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Proportion of Participants Who Indicate They Would be "Unlikely" Use Study Product in the Future
Likely
|
115 Participants
|
130 Participants
|
117 Participants
|
|
Proportion of Participants Who Indicate They Would be "Unlikely" Use Study Product in the Future
Unlikely
|
26 Participants
|
9 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Measured through Week 21Population: Serum TFV and Tissue TFV measures do not include participants from South Africa clinical sites.
PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=144 Participants
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=144 Participants
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=144 Participants
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
Serum TFV Cmax
|
337 ng/mL, ng/mg, ng/mL
Interval 257.0 to 447.0
|
332 ng/mL, ng/mg, ng/mL
Interval 257.0 to 406.0
|
3.9 ng/mL, ng/mg, ng/mL
Interval 2.2 to 7.9
|
|
Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
Tissue TFV
|
104 ng/mL, ng/mg, ng/mL
Interval 40.0 to 268.0
|
0.15 ng/mL, ng/mg, ng/mL
Interval 0.15 to 0.2
|
113 ng/mL, ng/mg, ng/mL
Interval 27.0 to 265.0
|
|
Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
Cervicovaginal lavage
|
1600000 ng/mL, ng/mg, ng/mL
Interval 500000.0 to 6500000.0
|
5380 ng/mL, ng/mg, ng/mL
Interval 6.0 to 201560.0
|
3100000 ng/mL, ng/mg, ng/mL
Interval 600000.0 to 8100000.0
|
SECONDARY outcome
Timeframe: Measured through Week 21This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=283 3-week periods
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=282 3-week periods
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=285 3-week periods
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Frequency of Product Use
Never
|
0 3-week periods
|
1 3-week periods
|
3 3-week periods
|
|
Frequency of Product Use
Less than once/week
|
1 3-week periods
|
1 3-week periods
|
0 3-week periods
|
|
Frequency of Product Use
1-3 times/week
|
7 3-week periods
|
5 3-week periods
|
9 3-week periods
|
|
Frequency of Product Use
4-6 times/week
|
48 3-week periods
|
59 3-week periods
|
41 3-week periods
|
|
Frequency of Product Use
Once/day
|
227 3-week periods
|
216 3-week periods
|
232 3-week periods
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: This outcome is based on evaluable participants.
This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=283 3-week periods
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=282 3-week periods
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=284 3-week periods
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Number of Days Product Missed
|
0.9 days
Standard Deviation 1.9
|
0.9 days
Standard Deviation 2.3
|
0.9 days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: This outcome is based on evaluable participants.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=144 Participants
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=144 Participants
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=144 Participants
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses
Yes
|
114 Participants
|
114 Participants
|
122 Participants
|
|
Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses
No
|
30 Participants
|
30 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Measured through Week 21This represents the rate during the past 3 weeks at which participants engaged in vaginal sex.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=264 3-week periods
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=272 3-week periods
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=271 3-week periods
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Frequency of Sexual Activity
Less than once/week
|
18 3-week periods
|
14 3-week periods
|
10 3-week periods
|
|
Frequency of Sexual Activity
1-3 times/week
|
170 3-week periods
|
179 3-week periods
|
184 3-week periods
|
|
Frequency of Sexual Activity
4-6 times/week
|
58 3-week periods
|
55 3-week periods
|
48 3-week periods
|
|
Frequency of Sexual Activity
Once/day
|
11 3-week periods
|
18 3-week periods
|
17 3-week periods
|
|
Frequency of Sexual Activity
More than once/day
|
7 3-week periods
|
6 3-week periods
|
12 3-week periods
|
SECONDARY outcome
Timeframe: Measured through Week 21Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=266 3-week periods
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=272 3-week periods
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=271 3-week periods
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Frequency of Male Condom Use
Never
|
71 3-week periods
|
80 3-week periods
|
69 3-week periods
|
|
Frequency of Male Condom Use
Rarely
|
19 3-week periods
|
21 3-week periods
|
28 3-week periods
|
|
Frequency of Male Condom Use
Sometimes
|
22 3-week periods
|
24 3-week periods
|
15 3-week periods
|
|
Frequency of Male Condom Use
Most of the time
|
26 3-week periods
|
27 3-week periods
|
28 3-week periods
|
|
Frequency of Male Condom Use
Always
|
128 3-week periods
|
120 3-week periods
|
131 3-week periods
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instance of vaginal intercourse on the same day as tablet use
These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=254 Sexual encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=266 Sexual encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Tablet Usage Before Sex
Yes
|
150 Sexual encounters
|
186 Sexual encounters
|
—
|
|
Tablet Usage Before Sex
No
|
104 Sexual encounters
|
80 Sexual encounters
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instances of vaginal sexual intercourse wherein tablets were used before the encounters. Timing data was not provided for four sexual encounters.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter).
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=148 Sexual Encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=184 Sexual Encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.
|
60.0 minutes
Interval 45.0 to 180.0
|
90.0 minutes
Interval 60.0 to 180.0
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instance of vaginal intercourse on the same day as tablet use
These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=255 Sexual Encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=266 Sexual Encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Tablet Usage After Sex
Yes
|
105 Sexual Encounters
|
83 Sexual Encounters
|
—
|
|
Tablet Usage After Sex
No
|
150 Sexual Encounters
|
183 Sexual Encounters
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instances of vaginal sexual intercourse wherein tablets were used after the encounters. Timing data was not provided for two sexual encounters.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter).
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=103 Sexual Encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=83 Sexual Encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.
|
90.0 minutes
Interval 45.0 to 180.0
|
120.0 minutes
Interval 60.0 to 240.0
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instance of vaginal intercourse on the same day as gel use
These summaries represent counts and percentages of participants using gel before last instance of vaginal sex.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=253 Sexual Encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=262 Sexual Encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Gel Usage Before Sex
Yes
|
142 Sexual Encounters
|
151 Sexual Encounters
|
—
|
|
Gel Usage Before Sex
No
|
111 Sexual Encounters
|
111 Sexual Encounters
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instances of vaginal sexual intercourse wherein gel was used before the encounters.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter).
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=142 Sexual Encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=151 Sexual Encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.
|
60.0 minutes
Interval 30.0 to 180.0
|
60.0 minutes
Interval 30.0 to 180.0
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instance of vaginal intercourse on the same day as gel use
These summaries represent counts and percentages of participants using gel after last instance of vaginal sex.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=254 Sexual Encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=261 Sexual Encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Gel Usage After Sex
Yes
|
112 Sexual Encounters
|
114 Sexual Encounters
|
—
|
|
Gel Usage After Sex
No
|
142 Sexual Encounters
|
147 Sexual Encounters
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Last instances of vaginal sexual intercourse wherein gel was used after the encounters.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter).
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=112 Sexual Encounters
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=114 Sexual Encounters
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.
|
75.0 minutes
Interval 52.5 to 180.0
|
120.0 minutes
Interval 60.0 to 240.0
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 21Population: Participants who completed a product sharing assessment at the end of the 6-week product use period.
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.
Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=139 Participants
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=142 Participants
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=141 Participants
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Reported Sharing of Product
|
2 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Measured through Week 21Outcome measures
| Measure |
Vaginal and Oral Tenofovir
n=168 Participants
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
|
Oral Tenofovir
n=168 Participants
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=168 Participants
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol
|
5 Participants
|
5 Participants
|
3 Participants
|
Adverse Events
Vaginal and Oral Tenofovir
Serious events: 1 serious events
Other events: 86 other events
Deaths: 0 deaths
Oral Tenofovir
Serious events: 3 serious events
Other events: 89 other events
Deaths: 0 deaths
Vaginal Tenofovir
Serious events: 1 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaginal and Oral Tenofovir
n=168 participants at risk
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
|
Oral Tenofovir
n=168 participants at risk
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=168 participants at risk
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.60%
1/168 • 21 Weeks
|
0.00%
0/168 • 21 Weeks
|
0.00%
0/168 • 21 Weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/168 • 21 Weeks
|
0.60%
1/168 • 21 Weeks
|
0.00%
0/168 • 21 Weeks
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion
|
0.00%
0/168 • 21 Weeks
|
0.60%
1/168 • 21 Weeks
|
0.00%
0/168 • 21 Weeks
|
|
Infections and infestations
Malaria
|
0.00%
0/168 • 21 Weeks
|
0.60%
1/168 • 21 Weeks
|
0.00%
0/168 • 21 Weeks
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/168 • 21 Weeks
|
0.00%
0/168 • 21 Weeks
|
0.60%
1/168 • 21 Weeks
|
Other adverse events
| Measure |
Vaginal and Oral Tenofovir
n=168 participants at risk
TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
|
Oral Tenofovir
n=168 participants at risk
TDF 300 mg tablet (oral tenofovir)
|
Vaginal Tenofovir
n=168 participants at risk
Tenofovir 1% gel (vaginal tenofovir)
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
10/168 • 21 Weeks
|
5.4%
9/168 • 21 Weeks
|
1.8%
3/168 • 21 Weeks
|
|
Gastrointestinal disorders
Nausea
|
14.3%
24/168 • 21 Weeks
|
14.9%
25/168 • 21 Weeks
|
3.0%
5/168 • 21 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
7/168 • 21 Weeks
|
7.1%
12/168 • 21 Weeks
|
1.2%
2/168 • 21 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
12/168 • 21 Weeks
|
10.1%
17/168 • 21 Weeks
|
6.0%
10/168 • 21 Weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.8%
3/168 • 21 Weeks
|
5.4%
9/168 • 21 Weeks
|
1.2%
2/168 • 21 Weeks
|
|
Investigations
Blood phosphorus decreased
|
3.0%
5/168 • 21 Weeks
|
6.5%
11/168 • 21 Weeks
|
3.6%
6/168 • 21 Weeks
|
|
Investigations
Haemoglobin decreased
|
4.8%
8/168 • 21 Weeks
|
4.8%
8/168 • 21 Weeks
|
6.5%
11/168 • 21 Weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.5%
26/168 • 21 Weeks
|
15.5%
26/168 • 21 Weeks
|
10.7%
18/168 • 21 Weeks
|
|
Nervous system disorders
Headache
|
8.3%
14/168 • 21 Weeks
|
4.8%
8/168 • 21 Weeks
|
1.8%
3/168 • 21 Weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.0%
10/168 • 21 Weeks
|
7.7%
13/168 • 21 Weeks
|
4.2%
7/168 • 21 Weeks
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
9.5%
16/168 • 21 Weeks
|
5.4%
9/168 • 21 Weeks
|
7.7%
13/168 • 21 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place