Status:
COMPLETED
Open Label Extension (OLE) of the TDF2 Study, Botswana
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Botswana Ministry of Health
Conditions:
HIV Infections
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief 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 pa...
Detailed Description
This open label phase builds on a unique opportunity provided by the end of the randomized phase of the TDF 2 study. The randomized study provided a well-characterized cohort of persons who received s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT04318210
Start Date
October 1 2012
End Date
July 1 2014
Last Update
May 13 2022
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