N/A
Completed N=229
Open Label Extension (OLE) of the TDF2 Study, Botswana
Source: ClinicalTrials.gov NCT04318210 ↗Enrolled (actual)
229
Serious AEs
3.5%
Results posted
May 2022
Primary outcomePrimary: Self-reported Drug Adherence Over the Past 3 Days — 199; 9; 2; 19 Participants
Summary
This study is an open label and is an extension to the TDF2 study in which the investigators offered daily oral tenofovir/emtricitabine (TDF/FTC) for a maximum of 12 months to HIV uninfected former participants of the TDF2 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Drug Adherence Over the Past 3 Days |
199; 9; 2; 19 | — |
| PRIMARY Number of Sex Partners |
0.87; 1.03 | — |
| PRIMARY Number of Sex Acts by Condom Usage |
4.01; 5.95; 1.28; 1.70; 2.72; 4.24 | — |
| PRIMARY Extracellular Tenofovir (TFV) for Recent Drug Exposure |
713; 64 | — |
| PRIMARY Intracellular Tenofovir-diphosphate (TFV-DP) |
141; 29; 20; 6; 12; 4 | — |
| SECONDARY HIV Seroconversion |
— | — |
| SECONDARY Serious Adverse Events |
2; 5; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Former TDF 2 participants
- Willing and able to provide informed written consent for participation
- If female, willing to use effective contraception during the trial (oral or injectable hormonal contraception, an intrauterine device [IUD], or who have had surgical interventions such as bilateral tubal ligation or hysterectomy)
- Laboratory values as follows within 30 days prior to enrollment:
- HIV uninfected by dual, parallel, rapid whole blood testing and HIV EIA
- Serum phosphorus ≥ 2.2 mg/dL
- Calculated creatinine clearance ≥ 60 mL/min
Exclusion Criteria
- Positive urine pregnancy test (females)
- Breastfeeding (females)
- History of significant renal or bone disease
- Any other clinical condition or prior therapy that, in the opinion of the physician would make the subject unsuitable for the OLE or unable to comply with the dosing requirements
Data sourced from ClinicalTrials.gov (NCT04318210). 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.