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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT03227861
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) viral load greater than or equal to (\>=) 5,000 copies per milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1 RNA viral load (\>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once within 1 week of initial HIV-1 RNA viral load test
* Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure prophylaxis (PrEP)
* Must be able to swallow whole tablets
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug
* A woman of childbearing potential must have a negative urine pregnancy test at screening
Exclusion Criteria:
* Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality
* Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF FDC)
* Known history of cirrhosis as diagnosed based on local practices
* Known history of chronic (\[\>=\] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (eGFR) less than (\<) 50 milliliter per minute (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula
* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03227861
Study Brief:
Protocol Section:
NCT03227861