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:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT05064020
Eligibility Criteria:
Inclusion Criteria:
* Adult individuals \> 18 years of age.
* Able and willing to provide informed/signed consent.
* Presence of HIV-1 infection as documented by a licensed ELISA test kit and confirmed by Western blot or HIV RNA.
* Current antiretroviral therapy, Genvoya or Stribild for HIV-1 infection.
* At least 1 or more concurrent prescription medication.
* HIV VL \< 50 for over 6 months, no current OI, no cancers
Exclusion Criteria:
* Use of drugs of abuse or alcohol which would interfere with adherence or completion of this study.
* Current antiretroviral therapy other than GenvoyaTM or StribildTM for HIV-1 infection.
* Pregnancy or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study entry and day of entry.
* Chronic, severe, or other medical conditions that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol.
* Use of prohibited protocol-specified drugs, prescription or over-the-counter medication (see Section 6.4.2) within 14 days prior to study entry.
* Moderate or severe cognitive impairment by history that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol
* Laboratory parameters documented within 21 days prior to study entry that would increase the risk for adverse events:
1. Hemoglobin \< 12.5 g/dL for men; \< 11.5 g/dL for women;
2. Platelet count \< 100,000 platelets/mm 3;
3. AST (SGOT) or ALT (SGPT) \> 1.5 x the upper limit of normal (ULN);
4. Estimated GFR \< 30 ml/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05064020
Study Brief:
Protocol Section:
NCT05064020