HIV/AIDS
Conditions
Interventions
Sponsors
Centre for the AIDS Programme of Research in Sauth Africa
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Female • Age 18-40 years (Phase I participants) • Age 18-30 years (Phase II participants) • Able and willing to provide written informed consent • Able and willing to provide adequate locator information for study retention purposes • HIV-negative on testing performed by study staff • Negative pregnancy test performed by study staff • Agree to use a reliable non-barrier form of contraception during the study and for at least 14 days before enrolment and until 30 days after implant removal (even if not currently sexually active) • In general, be in good health, as assessed clinically • Phase I participants must be at low risk of HIV infection
Exclusion criteria
Exclusion criteria: • Pregnant or currently breastfeeding, or intends to become pregnant and/or breastfeed during the study • Intends relocation from current residential area in the next 12 months • Haemoglobin the upper limit of normal (ULN) • Aspartate aminotransferase (AST) > ULN • Creatinine clearance ULN from a random sample • Past (< 6 months ago) or current participation in any other research study which may interfere with this study • Currently on tenofovir-containing oral PrEP drugs • Currently has a contraceptive implant, only if this would make it difficult to insert the study implant • Has a tattoo or other dermatological condition overlying the inner arm which in the opinion of the Principal Investigator or designee, may interfere with interpretation of insertion site reactions • Bleeding abnormality or on anti-coagulants • Active or planned use of prohibited medications as described in the Study Specific Procudures manual (updated regularly from the OCIS-001 Investigator’s Brochure) • Has any other condition that, based on the opinion of the Principal Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as assessed by mean percentage change in creatinine clearance from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess systemic and genital compartment PK of single and multiple TAF 110mg implant/s to determine in-human release rate characteristics, including to compare the PK profiles of insertion of two implants in one arm versus insertion of one implant in each arm. ;Acceptability - as assesses by participant views on the implant, by summarizing the insertion site reactions, by number of participants who report various insertion site reactions and by summarizing the mean healing time. The same information will be summarized for the placebo arm as the same insertion site reactions are expected as a result of insertion of the placebo implant.;HIV incidence as assessed by comparing the incidence of HIV in the sustained-release TAF implant (placebo tablet) arm with that in the TDF/FTC (placebo implant) arm;HIV viral load;Frequency of resistance mutations;Pregnancy rates;To assess the incidence of sexually transmitted infections (STIs), including (but not limited to) herpes simplex virus type 2 (HSV-2), human papillomavirus (HPV), gonorrhoea, chlamydia and trichomonas infections. | — |
Countries
South Africa
Contacts
Public ContactSmita Maharaj
Head Media and Communications
Outcome results
None listed