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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT02401828
Eligibility Criteria:
Inclusion Criteria:
* Documented HIV-1 positive by ELISA or Western Blot or Plasma HIV-RNA \>1000 c/ml.
* 18 years or older.
* HIV-RNA ≤50 copies/mL for ≥24 weeks.
* Historical baseline HIV-RNA plasma load \<100.000 c/ml
* CD4 count nadir pre-cART ≥200 cells/mm3
* Not on strong UGT1A1 or CYP3A4 inducing agents as stated in DTG SPC.
* General medical condition does not interfere with trial procedures (on investigators' discretion)
* Females should have no plans of becoming pregnant during the next 18 months after the baseline visit
* Females are eligible if:
1. They do not plan to become pregnant during the study
2. Negative screening pregnancy test and uses one of the following methods: 1.Abstinence from penile/vaginal intercourse during the study; 2.Double barrier contraceptive methods 1 of which must be condom.
Exclusion Criteria:
* Previous virological failure on any ART.
* Patient without documented anti-HBs antibodies.
* Subjects positive for hepatitis B at screening (HBsAg+).
* Any documented genotypic HIV-1 resistance with at least low-level resistance according to stanford HIV drug resistance database
* No record of the historical baseline plasma viral load available
* Subjects with concomitant CDC-C opportunistic infections within 90 days of screening.
* Subjects with history of allergy to INI.
* Subjects with creatinine clearance \<50mL/min according to CKD-EPI.
* Subjects with hepatic impairment of at least Child-Pugh B.
* Exposure to experimental drug or experimental HIV-1 vaccine within 90 days of start of DTG.
* Screening ALT \>5x ULN or ALT\>3xULN and bilirubin \>2 ULN.
* Patient (man or woman) planning or hoping to conceive a child/become pregnant during the study
* Patients who cannot take DTG 2 hours before or 6 hours after antacids, calciumcarbonate or iron supplements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02401828
Study Brief:
Protocol Section:
NCT02401828