Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT05735535
Eligibility Criteria:
Inclusion Criteria:
* Female individuals
* HIV-1 documented infection
* Age \> 18 years
* Being on an effective (pVL \< 50 copies/ml) three-drug cART regimen containing tenofovir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TDF/F/PI/c; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) for at least 3 months before the screening. Two consecutive HIV-1 RNA determinations below the determination threshold before enrollment are required
* No known allergy or intolerance to NRTIs, NNRTIs or INSTIs
* Women of childbearing potential will be required to adopt an effective birth control system throughout the study period
* Subjects able to comply with the protocol requirements
* Informed consent signed
Exclusion Criteria:
* Having failed virologically any previous ART regimen · Evidence of any 3TC (presence of M184V/I or K65R/E/N) or INSTI resistance · Having ever been treated with mono or dual ARV therapies subsequently intensified to three-drug cART regimen
* Pregnancy or breast-feeding or not willing to use effective contraception if they are of child bearing potential
* An active malignancy or OI requiring active treatment (prophylactic regimens are allowed) · HBV infection · A life expectancy \< 2 years
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT05735535
Study Brief:
Protocol Section:
NCT05735535