Open Label Extension (OLE) of the TDF2 Study, Botswana

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: Botswana Ministry of Health
• Treatments: Emtricitabine; Tenofovir

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