Study Stopped
Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial
Botswana Tenofovir Oral HIV Prophylaxis Trial
Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
2 other identifiers
interventional
1,200
2 countries
2
Brief Summary
This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2005
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2005
CompletedFirst Posted
Study publicly available on registry
May 18, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMarch 19, 2007
March 1, 2007
May 17, 2005
March 16, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse drug reactions in the tenofovir and placebo arms
HIV incidence in the tenofovir and placebo arms
Secondary Outcomes (4)
Changes in levels of unprotected sex during the trial
Adherence to medication
Antiretroviral (ARV) resistance patterns in seroconverters
Viral set point in seroconverters
Interventions
Eligibility Criteria
You may qualify if:
- citizen of Botswana 18-29 years old
- sexually active
- HIV uninfected
- Hepatitis B and C uninfected
- Calculated creatinine clearance \>= 60 mL/min
- hemoglobin \>= 8 gm/dL
- ALT and AST \<= 2x ULN
- total bilirubin \<= 1.5 mg/dL
- total serum amylase \<= 1.5x ULN
- Serum phosphorus \>= 2.2 mg/dL
- willing to use effective contraception
- living within 1 hours travel of study clinic
- pass comprehension test
- willing and able to give informed consent
You may not qualify if:
- history of significant renal or bone disease
- any chronic illness requiring ongoing prescription medication
- pregnant or breastfeeding
- planning to move away from site in the next year
- participating in another HIV prevention or vaccine safety trial
- any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centers for Disease Control and Preventionlead
- Botswana Ministry of Healthcollaborator
- Gilead Sciencescollaborator
Study Sites (2)
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333, United States
BOTUSA HIV Prevention Research Unit
Francistown and Gaborone, Botswana
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dawn K Smith, MD, MS, MPH
CDC and BOTUSA
- STUDY CHAIR
Lynn A Paxton, MD, MPH
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
May 17, 2005
First Posted
May 18, 2005
Study Start
September 1, 2005
Study Completion
March 1, 2007
Last Updated
March 19, 2007
Record last verified: 2007-03