Trial Outcomes & Findings for Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men (NCT NCT00131677)
NCT ID: NCT00131677
Last Updated: 2014-03-10
Results Overview
Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
400 participants
Primary outcome timeframe
24 months (immediate arm) and 15 months (delayed arm)
Results posted on
2014-03-10
Participant Flow
Recruitment began in 1/2005 and was completed in 7/2007. Participant follow-up was completed in July 2009. Participants were recruited from: San Francisco Dept. of Public Health AIDS Research Consortium of Atlanta Fenway Health
After an initial screening visit, participants were required to meet all enrollment criteria again at the enrollment visit.
Participant milestones
| Measure |
Tenofovir Disoproxil Fumarate
Participants received TDF 300mg orally daily for 24 months (immediate arm) or 15 months (delayed arm).
|
Placebo
Participants received matching placebo, to be taken daily.
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
199
|
|
Overall Study
COMPLETED
|
171
|
160
|
|
Overall Study
NOT COMPLETED
|
30
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
Baseline characteristics by cohort
| Measure |
Tenofovir Disoproxil Fumarate
n=201 Participants
Active arm: assigned to take TDF, 300mg po daily.
|
Placebo
n=199 Participants
Placebo arm--received matching placebo
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
201 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
201 participants
n=5 Participants
|
199 participants
n=7 Participants
|
400 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)Population: For biomedical outcomes, a treatment emergent cohort was defined. Participants entered the TE cohort with first dispense and exited with the first occurrence of: (1) completion of follow-up, (2) 30 days after permanent drug interruption, or (3) 30 days after last visit. For delayed arm participants,time before initiation of drug was excluded.
Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate
n=186 Participants
TDF, 300 mg orally daily
|
Placebo
n=187 Participants
Matching placebo daily
|
|---|---|---|
|
Clinical Safety--Creatinine Elevations
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 months (immediate arm), 15 months (delayed arm)Population: For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.
Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate
n=186 Participants
TDF, 300 mg orally daily
|
Placebo
n=187 Participants
Matching placebo daily
|
|---|---|---|
|
Clinical Safety--Hypophosphatemia
|
1 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)Population: For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.
Number of participants with HIV seroconversions occuring while on study drug
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate
n=186 Participants
TDF, 300 mg orally daily
|
Placebo
n=187 Participants
Matching placebo daily
|
|---|---|---|
|
Number of Breakthrough HIV Infections
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate
n=373 Participants
TDF, 300 mg orally daily
|
Placebo
Matching placebo daily
|
|---|---|---|
|
Adherence to Study Drug
|
77 percentage of doses
|
—
|
SECONDARY outcome
Timeframe: Nine monthsChange in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate
n=400 Participants
TDF, 300 mg orally daily
|
Placebo
Matching placebo daily
|
|---|---|---|
|
Behavioral Safety--Unprotected Anal Sex (UAS)
|
-9 percentage of ppts reporting UAS
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months (immediate arm), 15 months (delayed arm)Population: For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug. In addition, this analysis population includes only those participants for whom bone density analyses were performed.
Percent of San Francisco participants in the TDF vs. placebo groups who were found to have \>5% decline in Bone Mineral Density at the femoral neck.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate
n=94 Participants
TDF, 300 mg orally daily
|
Placebo
n=90 Participants
Matching placebo daily
|
|---|---|---|
|
>5% Bone Mineral Density Decline at Femoral Neck
|
13 percentage of participants
|
6 percentage of participants
|
Adverse Events
Tenofovir Disoproxil Fumarate
Serious events: 10 serious events
Other events: 149 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenofovir Disoproxil Fumarate
n=186 participants at risk
Active arm: assigned to take TDF, 300mg po daily.
|
Placebo
n=187 participants at risk
Matching placebo daily
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.54%
1/186 • Number of events 4 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
1.1%
2/187 • Number of events 2 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Infections and infestations
Appendicitis
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Infections and infestations
Appendicitis perforated
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/186 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/186 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/186 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
1.1%
2/187 • Number of events 2 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/186 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/186 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
General disorders
Pyrexia
|
0.00%
0/186 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.54%
1/186 • Number of events 3 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Psychiatric disorders
Mania
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.54%
1/186 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.00%
0/187 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/186 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
0.53%
1/187 • Number of events 1 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
Other adverse events
| Measure |
Tenofovir Disoproxil Fumarate
n=186 participants at risk
Active arm: assigned to take TDF, 300mg po daily.
|
Placebo
n=187 participants at risk
Matching placebo daily
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
37.6%
70/186 • Number of events 123 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
35.8%
67/187 • Number of events 127 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Gastrointestinal disorders
Diarrhea
|
17.7%
33/186 • Number of events 42 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
24.1%
45/187 • Number of events 57 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Nervous system disorders
Headache
|
12.9%
24/186 • Number of events 27 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
15.0%
28/187 • Number of events 33 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Psychiatric disorders
Depression
|
9.1%
17/186 • Number of events 21 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
12.8%
24/187 • Number of events 30 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Injury, poisoning and procedural complications
Gastroenteritis
|
10.2%
19/186 • Number of events 24 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
9.1%
17/187 • Number of events 25 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.4%
23/186 • Number of events 31 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
6.4%
12/187 • Number of events 14 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Gastrointestinal disorders
Flatulence
|
9.7%
18/186 • Number of events 21 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
9.6%
18/187 • Number of events 22 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
General disorders
Fatigue
|
9.1%
17/186 • Number of events 24 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
8.0%
15/187 • Number of events 17 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Gastrointestinal disorders
Nausea
|
10.8%
20/186 • Number of events 27 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
6.4%
12/187 • Number of events 13 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Infections and infestations
Influenza
|
8.6%
16/186 • Number of events 22 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
7.0%
13/187 • Number of events 17 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
16/186 • Number of events 21 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
5.9%
11/187 • Number of events 14 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Vascular disorders
Hypertension
|
6.5%
12/186 • Number of events 19 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
4.8%
9/187 • Number of events 10 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
16/186 • Number of events 18 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
5.3%
10/187 • Number of events 11 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
11/186 • Number of events 11 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
7.0%
13/187 • Number of events 16 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Psychiatric disorders
Insomnia
|
5.4%
10/186 • Number of events 10 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
6.4%
12/187 • Number of events 14 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Psychiatric disorders
Anxiety
|
3.8%
7/186 • Number of events 8 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
8.0%
15/187 • Number of events 16 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Nervous system disorders
Dizziness
|
7.5%
14/186 • Number of events 17 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
3.7%
7/187 • Number of events 9 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Infections and infestations
Herpes simplex
|
1.6%
3/186 • Number of events 7 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
6.4%
12/187 • Number of events 15 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.8%
7/186 • Number of events 7 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
5.3%
10/187 • Number of events 10 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
6/186 • Number of events 8 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
5.3%
10/187 • Number of events 10 • Maximum time period on drug of 24 months for immediate arm participants and 15 months for delayed arm participants.
Treatment emergent cohort: participants enter cohort when study drug is initiated, and exit at the first occurence of one of these events: 1) completion of study visits, 2)30 days after loss to follow up, or 3)30 days after start of permanent drug interruption.
|
Additional Information
Taraz Samandari
Centers for Disease Control and Prevention (CDC)
Phone: 404-639-1676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All presentations and publications of data from CDC funded studies are subject to CDC clearance prior to publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER