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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT04979468
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 documented infection;
* Aged 18 years or older at the time of signing the informed consent;
* Stable INSTI-based first-line three-drug ART (switch between different NRTIs are allowed; e.g. from TDF/FTC to TAF/FTC or ABC/3TC, from TAF/FTC to TDF/FTC or ABC/3TC, from ABC/3TC to TAF/FTC or TDF/FTC). Any change of INSTI will not be allowed. Only the following regimens will be allowed:
* RAL 1200 mg QD plus TDF/FTC or TAF/FTC;
* RAL 1200 mg QD plus ABC/3TC;
* EVG/COBI/FTC/TDF or EVG/COBI/FTC/TAF;
* DTG plus TDF/FTC or TAF/FTC;
* DTG/ABC/3TC or DTG plus ABC/3TC;
* BIC/TAF/FTC
* Previous INSTI-based first-line ART lasting less than 18 months before screening;
* To have reached a HIV-1 RNA \<50 copies/mL during INSTI first-line therapy for less than 12 months. At least a single HIV-1 RNA determination below the threshold within the 6 months before enrollment is required (if a following determination in present, this should not be ≥50 copies (cp)/mL)
* HIV-1 RNA below 50 copies/mL at the screening visit;
* No known allergy or intolerance to the study drugs or their components or drugs of their class;
* A female person is eligible to enter the study if it is confirmed that she is:
* Not pregnant confirmed by a negative serum pregnancy test at both Screening and Day1;
* Not breastfeeding;
* Of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy;
* Of childbearing potential and agrees to utilize the protocol specified method of contraception (as defined in Appendix 1 -Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential) or be non-heterosexually active or practice sexual abstinence (defined as complete abstinence from penile-vaginal intercourse; periodic abstinence, e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) from screening throughout the duration of study treatment and for at least two weeks following discontinuation of study drugs;
* Being able to comply with the protocol requirements and restrictions;
* Signature of written Informed Consent Form (participants or legal guardian) before that any protocol-specified assessments are conducted.
Exclusion Criteria:
A person will be considered not eligible for inclusion in this study if any of the following criteria apply:
* Having failed virologically;
* Having changed the INSTI drug;
* Any major INSTI- or NRTI-resistance-associated mutation documented before starting ART;
* Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study;
* Evidence of Hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-Hbc), hepatitis B surface antigen antibody (anti-HBs) and, possibly, HBV DNA as follows:
* Individuals positive for HBsAg are excluded;
* Individuals negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded;
* HCV-RNA positivity needing for any hepatitis C virus (HCV) therapy during the study;
* Ongoing malignancy other than cutaneous Kaposi's sarcoma (not requiring systemic therapy), basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia;
* Active opportunistic infections requiring active treatment;
* Creatinine clearance of \<50 mL/min/1.73m2 via CKD-EPI method;
* Individuals with severe hepatic impairment (Child Pugh class C) and/or unstable liver disease;
* Any verified Grade 4 laboratory abnormality at screening assessment;
* Alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN) or ALT \>3xULN and bilirubin \>1.5xULN (with \>35% direct bilirubin) at screening assessment;
* Receipt of investigational research agents within 30 days prior to study entry;
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening;
* Receipt of immunosuppressive medications or immune-modulators within the past 6 months;
* Individuals who in the investigator's judgment, poses a significant suicidality risk or with diagnosed major depression, Bipolar Disorders and Psychoses
* A life expectancy estimated as less than 2 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04979468
Study Brief:
Protocol Section:
NCT04979468