Phase 3
Completed N=1,219
Botswana TDF/FTC Oral HIV Prophylaxis Trial
Source: ClinicalTrials.gov NCT00448669 ↗Enrolled (actual)
1,219
Serious AEs
7.0%
Results posted
Feb 2020
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
2,023citations · ~145 / year
Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.
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.
Linked Publications (5)
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Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.
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Evaluation of Sexual Risk Behavior Among Study Participants in the TDF2 PrEP Study Among Heterosexual Adults in Botswana.
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Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana.
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Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010.
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CD4(+) cell count, viral load, and drug resistance patterns among heterosexual breakthrough HIV infections in a study of oral preexposure prophylaxis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.