Open Label Extension (OLE) of the TDF2 Study, Botswana (NCT04318210) | Clinical Trial Compass
CompletedNot Applicable
Open Label Extension (OLE) of the TDF2 Study, Botswana
229 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-reported Drug Adherence Over the Past 3 Days
Timeframe: Up to 12 Months
2
Number of Sex Partners
Timeframe: Up to 12 months
3
Number of Sex Acts by Condom Usage
Timeframe: Up to 12 months
4
Extracellular Tenofovir (TFV) for Recent Drug Exposure