Trial Outcomes & Findings for Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy (NCT NCT04050371)
NCT ID: NCT04050371
Last Updated: 2021-05-11
Results Overview
Tenofovir diphosphate concentration in dried blood spots at week 4
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
After 4 weeks of daily observed dosing of FTC/TDF
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
Transgender Men
Transgender men on stable testosterone regimen from the iBreathe Study
|
Transgender Women
Transgender women on stable estradiol treatment from the iBreathe study.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Transgender Men
Transgender men on stable testosterone regimen from the iBreathe Study
|
Transgender Women
Transgender women on stable estradiol treatment from the iBreathe study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
Baseline characteristics by cohort
| Measure |
Transgender Women
n=24 Participants
Transgender women on stable estradiol treatment.
|
Transgender Men
n=24 Participants
Transgender men on stable testosterone regimen.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
34 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Gender Identity
Transgender women
|
24 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Gender Identity
Transgender men
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Weight (kg)
|
74 kg
n=5 Participants
|
75 kg
n=7 Participants
|
75 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: After 4 weeks of daily observed dosing of FTC/TDFTenofovir diphosphate concentration in dried blood spots at week 4
Outcome measures
| Measure |
Transgender Women
n=24 Participants
Transgender women on stable estradiol treatment.
|
Transgender Men
n=23 Participants
Transgender men on stable testosterone regimen.
|
|---|---|---|
|
Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS)
|
973.5 fmol/punch
Interval 708.0 to 1138.5
|
1078 fmol/punch
Interval 899.0 to 1181.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and after 4 weeks of daily FTC/TDFEstradiol concentrations in blood plasma by LC-MS/MS
Outcome measures
| Measure |
Transgender Women
n=24 Participants
Transgender women on stable estradiol treatment.
|
Transgender Men
n=23 Participants
Transgender men on stable testosterone regimen.
|
|---|---|---|
|
Estradiol Concentration
Week 0
|
141.5 pg/mL
Interval 89.5 to 253.0
|
24.2 pg/mL
Interval 11.6 to 30.3
|
|
Estradiol Concentration
Week 4
|
116 pg/mL
Interval 68.8 to 310.0
|
23.1 pg/mL
Interval 13.2 to 30.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and after 4 weeks of daily FTC/TDFTotal testosterone concentrations in blood plasma by LC-MS/MS
Outcome measures
| Measure |
Transgender Women
n=24 Participants
Transgender women on stable estradiol treatment.
|
Transgender Men
n=23 Participants
Transgender men on stable testosterone regimen.
|
|---|---|---|
|
Total Testosterone
Week 0
|
56.5 ng/dL
Interval 35.3 to 71.9
|
559 ng/dL
Interval 294.0 to 747.0
|
|
Total Testosterone
Week 4
|
56.7 ng/dL
Interval 36.6 to 85.0
|
595 ng/dL
Interval 383.0 to 845.0
|
Adverse Events
Transgender Women
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Transgender Men
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transgender Women
n=24 participants at risk
Transgender Women (Male sex assigned at birth).
|
Transgender Men
n=24 participants at risk
Transgender men (Female sex assigned at birth)
|
|---|---|---|
|
Blood and lymphatic system disorders
HIV infection
|
0.00%
0/24 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/24 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea or soft stools
|
8.3%
2/24 • Number of events 2 • 4 weeks
|
8.3%
2/24 • Number of events 2 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • 4 weeks
|
25.0%
6/24 • Number of events 6 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
General disorders
lightheaded
|
0.00%
0/24 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Fever
|
0.00%
0/24 • 4 weeks
|
8.3%
2/24 • Number of events 2 • 4 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
8.3%
2/24 • Number of events 2 • 4 weeks
|
|
Metabolism and nutrition disorders
Fatigue
|
0.00%
0/24 • 4 weeks
|
12.5%
3/24 • Number of events 3 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
8.3%
2/24 • Number of events 2 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place