Phase 3
N=1,219
Botswana TDF/FTC Oral HIV Prophylaxis Trial
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00448669 ↗Enrolled (actual)
1,219
Serious AEs
7.0%
Results posted
Feb 2020
Primary outcome: Primary: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms — 91.2; 88.2 percentage of participants with AE — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centers for Disease Control and Prevention
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms |
91.2; 88.2 | 0.003 sig |
| PRIMARY HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms |
1.2; 3.1 | 0.03 sig |
| SECONDARY Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts |
124; 113; 94; 86; 97; 90 | 0.004 sig |
| SECONDARY Rates of Adherence to Study Medication |
93.5; 93.6 | 0.79 |
| SECONDARY Antiretroviral (ARV) Resistance Patterns in Seroconverters |
1; 1 | — |
| SECONDARY CD4 Evaluation After HIV Seroconversion |
500; 466 | — |
Summary
This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.
Eligibility Criteria
Inclusion Criteria
- citizen of Botswana 18-39 years old
- sexually active
- HIV uninfected
- Hepatitis B and C uninfected
- Calculated creatinine clearance >= 60 mL/min
- hemoglobin >= 8 gm/dL
- ALT and AST = 2.2 mg/dL
- willing to use hormonal contraception (females)
- living within 1 hours travel of study clinic
- pass comprehension test
- willing and able to give informed consent
Exclusion Criteria
- 18-20 without parent/guardian consent
- 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
Data sourced from ClinicalTrials.gov (NCT00448669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.