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 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT01479634
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection diagnosed by a rapid HIV test or any licensed ELISA test kit and documented in the participant's medical chart and re-verified at the time of study screening (hereafter: "screen date").
* Most recent CD4+ cell count ≥ 250 cells/uL:
Arm A: CD4+ cell count 250-350 cells/uL Arm B: CD4+ cell count \>350 cells/uL
* Age ≥ 18 years.
* Residence within a 30 kilometer radius of the Bwizibwera HC-IV.
* Willing to initiate ART if the CD4+ cell count is ≥ 350 cells/uL.
* The following laboratory values obtained at the screening visit:
* Absolute neutrophil count (ANC) ≥ 500 cells/uL
* Hemoglobin ≥ 7.0 g/dL
* Platelet count ≥ 50,000/uL
* ALT (SGPT) ≤ 5 times greater than the upper limit of normal
* Estimated glomerular filtration rate (eGFR) of ≥ 60 mL/minute by the Modification of Diet in Renal Disease (MDRD) formula:
eGFR = 186 \* Serum creatinine-1.154 \* Age-0.203 \* \[1.21 if African\] \* \[0.742 if female\]
* Ability to swallow oral medications.
* Ability and willingness of participant to give informed written consent.
Exclusion Criteria:
* Receipt at any time prior to study entry of \> 7 days cumulative treatment with any ARV or combination of ARVs, except ARVs taken for any length of time during pregnancy for the prevention of mother to child transmission (pMTCT) or ARVs taken for occupational exposure.
* For Arm B participants only: allergy/sensitivity to TDF, FTC, EFV, RTV, LPV or formulations of any of these three medications, or to co-formulated Truvada®.
* Active World Health Organization (WHO) HIV stage 3 or 4 illness
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01479634
Study Brief:
Protocol Section:
NCT01479634