Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men (iPrEx)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00458393 |
Recruitment Status :
Completed
First Posted : April 10, 2007
Results First Posted : January 24, 2018
Last Update Posted : November 2, 2021
|
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Condition |
HIV Infections |
Interventions |
Drug: daily TDF/FTC Drug: Placebo |
Enrollment | 2499 |
Participant Flow
Recruitment Details | The study recruited HIV uninfected participants whose sexual practices put them at risk for HIV infection. They were recruited from community clinics. |
Pre-assignment Details |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
![]() |
Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate |
Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Period Title: Overall Study | ||
Started | 1251 | 1248 |
Completed | 942 | 953 |
Not Completed | 309 | 295 |
Reason Not Completed | ||
Withdrawal by Subject | 67 | 80 |
Physician Decision | 31 | 22 |
Relocated | 77 | 81 |
Lost to Follow-up | 115 | 92 |
Sites marked other on the form. | 19 | 20 |
Baseline Characteristics
Arm/Group Title | TDF/FTC | Placebo | Total | |
---|---|---|---|---|
![]() |
Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate |
Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Total of all reporting groups | |
Overall Number of Baseline Participants | 1251 | 1248 | 2499 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1251 participants | 1248 participants | 2499 participants | |
<=18 years |
92 7.4%
|
101 8.1%
|
193 7.7%
|
|
Between 18 and 65 years |
1158 92.6%
|
1147 91.9%
|
2305 92.2%
|
|
>=65 years |
1 0.1%
|
0 0.0%
|
1 0.0%
|
|
Age, Continuous
Median (Full Range) Unit of measure: Years |
||||
Number Analyzed | 1251 participants | 1248 participants | 2499 participants | |
25
(18 to 67)
|
24
(18 to 63)
|
24
(18 to 67)
|
||
Sex/Gender, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 1251 participants | 1248 participants | 2499 participants |
Male Sex at Birth. Identify Trans |
155 12.4%
|
155 12.4%
|
310 12.4%
|
|
Male Sex at Birth. Identify Female |
15 1.2%
|
14 1.1%
|
29 1.2%
|
|
Male Sex at Birth. Identify Male |
1081 86.4%
|
1079 86.5%
|
2160 86.4%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1251 participants | 1248 participants | 2499 participants |
Ecuador | 150 | 150 | 300 | |
United States | 113 | 114 | 227 | |
Brazil | 186 | 184 | 370 | |
South Africa | 45 | 43 | 88 | |
Thailand | 57 | 57 | 114 | |
Peru | 700 | 700 | 1400 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | David Glidden |
Organization: | University of California, San Francisco |
Phone: | 415-514-8009 |
EMail: | david.glidden@ucsf.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00458393 |
Obsolete Identifiers: | NCT00350324 |
Other Study ID Numbers: |
CO-US-104-0288 10445 ( Registry Identifier: DAIDS ES ) 1U01AI064002 ( U.S. NIH Grant/Contract ) iPrEx ( Other Identifier: Study team ) |
First Submitted: | April 6, 2007 |
First Posted: | April 10, 2007 |
Results First Submitted: | December 27, 2016 |
Results First Posted: | January 24, 2018 |
Last Update Posted: | November 2, 2021 |