Trial Outcomes & Findings for Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States (NCT NCT00936715)
NCT ID: NCT00936715
Last Updated: 2017-06-02
Results Overview
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Up to 240 weeks
Results posted on
2017-06-02
Participant Flow
Participants were enrolled at study sites in the US. The first participant was screened on 06 Aug 2009. The last study visit occurred on 20 November 2015.
51 participants were screened.
Participant milestones
| Measure |
FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®) (200/300 mg) fixed dose combination (FDC) tablet administered once daily for up to 240 weeks.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®) (200/300 mg) fixed dose combination (FDC) tablet administered once daily for up to 240 weeks.
|
|---|---|
|
Overall Study
Investigators Discretion
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Safety or Tolerability Reasons
|
4
|
Baseline Characteristics
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
Baseline characteristics by cohort
| Measure |
FTC/TDF
n=24 Participants
FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
|
|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or American African
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 240 weeksPopulation: Participants who were enrolled into the study and received study drug.
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
Outcome measures
| Measure |
FTC/TDF
n=24 Participants
FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
|
|---|---|
|
Number of Participants Who Had Access to, and Received the Intervention
|
24 Participants
|
Adverse Events
FTC/TDF
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FTC/TDF
n=24 participants at risk
FTC/TDF (200/300 mg) FDC tablet administered orally once daily for up to 240 weeks
|
|---|---|
|
Hepatobiliary disorders
Bile duct obstruction Hepatobiliary disorders
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Psychiatric disorders
Bipolar disorder
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Renal and urinary disorders
Hydronephrosis
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Renal and urinary disorders
Renal failure
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Surgical and medical procedures
Appendicectomy
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Surgical and medical procedures
Lung lobectomy
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
|
Vascular disorders
Deep vein thrombosis
|
4.2%
1/24 • Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER