Trial Outcomes & Findings for Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel (NCT NCT01687218)
NCT ID: NCT01687218
Last Updated: 2021-06-24
Results Overview
Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
27 weeks (three 8-week product use periods with 1-week washout periods between them)
Results posted on
2021-06-24
Participant Flow
HIV-uninfected males or transgender females who were 18 years of age or older who practice receptive anal intercourse were recruited from September 2013 through November 2014 from 8 sites in Peru, Puerto Rico, South Africa, Thailand and USA.
349 persons were screened and 154 were excluded for various reasons. The study enrolled 195 participants, 187 of whom are evaluable. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.
Participant milestones
| Measure |
Group 1
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 2
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 3
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 4
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 5
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 6
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
31
|
34
|
33
|
32
|
|
Overall Study
COMPLETED
|
30
|
29
|
30
|
32
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 2
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 3
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 4
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 5
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 6
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
0
|
1
|
1
|
0
|
|
Overall Study
Relocated, no follow-up planned
|
1
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
Baseline characteristics by cohort
| Measure |
Group 1
n=33 Participants
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 2
n=32 Participants
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 3
n=31 Participants
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 4
n=34 Participants
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 5
n=33 Participants
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Group 6
n=32 Participants
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
32.2 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
31.4 years
STANDARD_DEVIATION 7.8 • n=10 Participants
|
31.1 years
STANDARD_DEVIATION 9.3 • n=115 Participants
|
|
Age, Customized
Under 20
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
10 participants
n=115 Participants
|
|
Age, Customized
20-24
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
7 participants
n=21 Participants
|
5 participants
n=10 Participants
|
44 participants
n=115 Participants
|
|
Age, Customized
25-29
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
6 participants
n=10 Participants
|
43 participants
n=115 Participants
|
|
Age, Customized
30-34
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
10 participants
n=10 Participants
|
40 participants
n=115 Participants
|
|
Age, Customized
35-39
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=10 Participants
|
20 participants
n=115 Participants
|
|
Age, Customized
40-44
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=10 Participants
|
19 participants
n=115 Participants
|
|
Age, Customized
45-49
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=10 Participants
|
11 participants
n=115 Participants
|
|
Age, Customized
50+
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=10 Participants
|
8 participants
n=115 Participants
|
|
Sex/Gender, Customized
Man
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
22 participants
n=5 Participants
|
27 participants
n=4 Participants
|
26 participants
n=21 Participants
|
24 participants
n=10 Participants
|
141 participants
n=115 Participants
|
|
Sex/Gender, Customized
Woman
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
Sex/Gender, Customized
Transgender/Transwoman
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=10 Participants
|
19 participants
n=115 Participants
|
|
Sex/Gender, Customized
Other
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
27 participants
n=115 Participants
|
|
Sex/Gender, Customized
Refuse to answer
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Hispanic Origin
Yes
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
12 participants
n=21 Participants
|
8 participants
n=10 Participants
|
55 participants
n=115 Participants
|
|
Hispanic Origin
No
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
26 participants
n=4 Participants
|
21 participants
n=21 Participants
|
24 participants
n=10 Participants
|
140 participants
n=115 Participants
|
|
Highest Level of Education
no schooling
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Highest Level of Education
primary school, not complete
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Highest Level of Education
primary school, complete
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Highest Level of Education
secondary school, not complete
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=10 Participants
|
9 participants
n=115 Participants
|
|
Highest Level of Education
secondary school, complete
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=10 Participants
|
27 participants
n=115 Participants
|
|
Highest Level of Education
attended college or university
|
29 participants
n=5 Participants
|
26 participants
n=7 Participants
|
23 participants
n=5 Participants
|
28 participants
n=4 Participants
|
26 participants
n=21 Participants
|
24 participants
n=10 Participants
|
156 participants
n=115 Participants
|
|
Sexual Orientation (CASI)
Gay/Homosexual
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
27 participants
n=5 Participants
|
32 participants
n=4 Participants
|
28 participants
n=21 Participants
|
31 participants
n=10 Participants
|
171 participants
n=115 Participants
|
|
Sexual Orientation (CASI)
Bisexual
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=10 Participants
|
13 participants
n=115 Participants
|
|
Sexual Orientation (CASI)
Straight/Heterosexual
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Sexual Orientation (CASI)
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
5 participants
n=115 Participants
|
|
Sexual Orientation (CASI)
Refuse to answer
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Nationality
Puerto Rico
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=10 Participants
|
7 participants
n=115 Participants
|
|
Nationality
Peru
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
6 participants
n=10 Participants
|
38 participants
n=115 Participants
|
|
Nationality
South Africa
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
18 participants
n=115 Participants
|
|
Nationality
Thailand
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=10 Participants
|
54 participants
n=115 Participants
|
|
Nationality
U.S.A.
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
15 participants
n=4 Participants
|
12 participants
n=21 Participants
|
13 participants
n=10 Participants
|
78 participants
n=115 Participants
|
|
Race - Puerto Rico
White
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race - Puerto Rico
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - Puerto Rico
Mixed
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race - Puerto Rico
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race - Puerto Rico
Indigenous
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - Puerto Rico
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race - Peru
White
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race - Peru
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - Peru
Mixed
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
5 participants
n=10 Participants
|
24 participants
n=115 Participants
|
|
Race - Peru
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - Peru
Indigenous
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
1 participants
n=10 Participants
|
13 participants
n=115 Participants
|
|
Race - Peru
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - South Africa
Other African tribe
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race - South Africa
White
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - South Africa
Zulu
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - South Africa
Xhosa
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=10 Participants
|
14 participants
n=115 Participants
|
|
Race - South Africa
Indian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - South Africa
Colored
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race - South Africa
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race - Thailand
Indian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - Thailand
Mixed
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - Thailand
Thai
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=10 Participants
|
54 participants
n=115 Participants
|
|
Race - Thailand
Chinese
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - Thailand
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - U.S.A.
White
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
12 participants
n=4 Participants
|
6 participants
n=21 Participants
|
10 participants
n=10 Participants
|
61 participants
n=115 Participants
|
|
Race - U.S.A.
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
Race - U.S.A.
Mixed
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race - U.S.A.
Black/African-American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Race - U.S.A.
American Indian/Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - U.S.A.
Native-Hawaiian or other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race - U.S.A.
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=10 Participants
|
8 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Among the 187 evaluable participants. One participant was terminated before the Initiate Period visit of his/her Period 3 (Oral Tablet regimen period). Thus, this participant is removed from the analysis of the oral period regimen.
Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).
Outcome measures
| Measure |
Product 1
n=186 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=187 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=187 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Safety: Grade 2 or Higher Adverse Events
|
64 participants
|
61 participants
|
56 participants
|
PRIMARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.
Outcome measures
| Measure |
Product 1
n=179 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=181 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=183 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?
Disliked Very Much/A Little
|
16 participants
|
47 participants
|
38 participants
|
|
Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?
Liked Very Much/A Little
|
163 participants
|
134 participants
|
145 participants
|
PRIMARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.
Outcome measures
| Measure |
Product 1
n=183 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=184 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=183 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?
Very Difficult/Difficult
|
14 participants
|
24 participants
|
18 participants
|
|
Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?
Very Easy/Easy
|
169 participants
|
160 participants
|
165 participants
|
PRIMARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.
Outcome measures
| Measure |
Product 1
n=183 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=184 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=176 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?
Very Unlikely/Unlikely
|
24 participants
|
52 participants
|
31 participants
|
|
Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?
Very Likely/Likely
|
159 participants
|
132 participants
|
145 participants
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Participant periods with tenofovir concentrations (log10 ng/mL) in blood plasma among evaluable participants.
Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
Outcome measures
| Measure |
Product 1
n=184 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=184 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=183 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma
Mid-Period TFV Concentration
|
1.85 log10 ng/mL
Standard Deviation 0.59
|
0.42 log10 ng/mL
Standard Deviation 0.83
|
-0.01 log10 ng/mL
Standard Deviation 0.89
|
|
Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma
End Period TFV Concentration
|
1.77 log10 ng/mL
Standard Deviation 0.71
|
0.37 log10 ng/mL
Standard Deviation 0.84
|
-0.02 log10 ng/mL
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Participant end periods with tenofovir concentrations (log10 ng/mg) in rectal tissue among evaluable participants.
Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
Outcome measures
| Measure |
Product 1
n=36 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=36 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=36 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue
|
0.18 log10 ng/mg
Standard Deviation 0.51
|
0.84 log10 ng/mg
Standard Deviation 0.50
|
0.02 log10 ng/mg
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Participant periods with tenofovir concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants.
Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
Outcome measures
| Measure |
Product 1
n=186 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=183 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=184 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
Initiate Period TFV Concentration
|
-1.53 log10 ng/mg
Standard Deviation 1.20
|
-1.65 log10 ng/mg
Standard Deviation 1.12
|
-1.29 log10 ng/mg
Standard Deviation 1.42
|
|
Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
Mid-Period TFV Concentration
|
0.71 log10 ng/mg
Standard Deviation 1.22
|
0.97 log10 ng/mg
Standard Deviation 1.64
|
-0.03 log10 ng/mg
Standard Deviation 1.54
|
|
Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
End Period TFV Concentration
|
0.66 log10 ng/mg
Standard Deviation 1.31
|
1.00 log10 ng/mg
Standard Deviation 1.42
|
0.01 log10 ng/mg
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Participant periods with emtricitabine (FTC) concentrations (log10 ng/mL) in blood plasma among evaluable participants.
Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
Outcome measures
| Measure |
Product 1
n=184 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=184 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=183 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma
Mid-Period FTC Concentration
|
2.34 log10 ng/mL
Standard Deviation 0.82
|
-0.35 log10 ng/mL
Standard Deviation 1.00
|
-0.37 log10 ng/mL
Standard Deviation 0.98
|
|
Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma
End Period FTC Concentration
|
2.25 log10 ng/mL
Standard Deviation 0.96
|
-0.37 log10 ng/mL
Standard Deviation 0.98
|
-0.33 log10 ng/mL
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Participant end periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal tissue among evaluable participants.
Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
Outcome measures
| Measure |
Product 1
n=36 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=36 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=36 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue
|
-0.35 log10 ng/mg
Standard Deviation 0.33
|
-1.26 log10 ng/mg
Standard Deviation 0.00
|
-1.26 log10 ng/mg
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Participant periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants.
Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
Outcome measures
| Measure |
Product 1
n=186 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=183 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=184 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
Initiate Period FTC Concentration
|
-1.75 log10 ng/mg
Standard Deviation 0.80
|
-1.76 log10 ng/mg
Standard Deviation 0.73
|
-1.57 log10 ng/mg
Standard Deviation 1.00
|
|
Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
Mid-Period FTC Concentration
|
0.31 log10 ng/mg
Standard Deviation 1.14
|
-1.76 log10 ng/mg
Standard Deviation 0.76
|
-1.67 log10 ng/mg
Standard Deviation 0.91
|
|
Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
End Period FTC Concentration
|
0.14 log10 ng/mg
Standard Deviation 1.30
|
-1.80 log10 ng/mg
Standard Deviation 0.69
|
-1.69 log10 ng/mg
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Participant end periods with tenofovir-diphosphate (TFV-DP) concentrations (log10 ng/mg) in rectal tissue among evaluable participants.
Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
Outcome measures
| Measure |
Product 1
n=36 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=36 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=36 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue
|
1.52 log10 ng/mg
Standard Deviation 0.50
|
2.06 log10 ng/mg
Standard Deviation 0.52
|
1.54 log10 ng/mg
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)Population: Evaluable participants with Final Converged Rates of prescribed doses.
Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing.
Outcome measures
| Measure |
Product 1
n=185 Participants
Oral (Daily FTC/TDF)
|
Product 2
n=184 Participants
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=183 Participants
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period
At or Greater than 80%
|
173 Participants
|
153 Participants
|
170 Participants
|
|
Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period
Less Than 80%
|
12 Participants
|
31 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)To assess correlation of PK with adherence measures
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)To examine whether sexual activity or condom use varies by product used
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)To determine the level of sharing of study products with non-participants and to assess with whom products are shared
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use
Outcome measures
Outcome data not reported
Adverse Events
Product 1
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
Product 2
Serious events: 2 serious events
Other events: 103 other events
Deaths: 0 deaths
Product 3
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Product 1
n=192 participants at risk
Oral (Daily FTC/TDF)
|
Product 2
n=192 participants at risk
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=191 participants at risk
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.52%
1/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.00%
0/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.52%
1/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.00%
0/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Psychiatric disorders
Suicide attempt
|
0.52%
1/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.00%
0/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.00%
0/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
Other adverse events
| Measure |
Product 1
n=192 participants at risk
Oral (Daily FTC/TDF)
|
Product 2
n=192 participants at risk
Rectal (Daily TFV RG 1% gel)
|
Product 3
n=191 participants at risk
Rectal (RAI-associated TFV RG 1% gel)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
4/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.0%
2/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.1%
6/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
8/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
2.6%
5/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.7%
7/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Anal fissure
|
0.52%
1/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.6%
7/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.7%
7/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.1%
6/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.6%
3/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Defaecation urgency
|
1.0%
2/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
8.3%
16/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
5.8%
11/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
14/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
11.5%
22/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
7.9%
15/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
7/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.6%
3/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.00%
0/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
12/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
12.0%
23/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
7.3%
14/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Gastrointestinal mucosa hyperaemia
|
0.52%
1/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.1%
6/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.0%
2/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Nausea
|
7.8%
15/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
2.1%
4/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.0%
2/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Proctalgia
|
1.6%
3/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.6%
7/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
2.1%
4/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.1%
4/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
4.7%
9/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
2.6%
5/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.6%
7/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.6%
3/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
6/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
2.1%
4/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.52%
1/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
General disorders
Fatigue
|
3.1%
6/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
0.52%
1/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.0%
2/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
12/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
5.2%
10/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
10.5%
20/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Infections and infestations
Proctitis chlamydial
|
4.7%
9/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
4.2%
8/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
6.8%
13/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Infections and infestations
Proctitis gonococcal
|
2.6%
5/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.6%
3/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.1%
6/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
5/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
5.2%
10/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
5.8%
11/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.6%
7/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
5.7%
11/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
5.2%
10/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Nervous system disorders
Dizziness
|
4.7%
9/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
1.6%
3/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.1%
6/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Nervous system disorders
Headache
|
8.9%
17/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
4.7%
9/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.7%
7/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
3/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
3.1%
6/192 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
2.6%
5/191 • 27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
|
Additional Information
Ross D. Cranston, MD, FRCP
Division of Infectious Diseases - UPMC
Phone: 412-383-2054
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place