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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT03118661
Eligibility Criteria:
Inclusion Criteria (Step 1)
* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.
* Receipt of allo-HCT for any indication at least 100 days prior to study entry.
* Receipt of maraviroc for at least 30 days starting at date of transplant. Longer receipt of maraviroc is acceptable. Documentation of HIV-1 tropism for CCR5 should be obtained if available, but it is not necessary that the participant have prior CCR5-tropic.
* At least 18 years of age.
* HIV-1 RNA that is \<50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 45 days prior to study entry.
* For females of reproductive potential (i.e., women who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative urine pregnancy test (with a sensitivity of 15-25 mIU/mL) within 48 hours prior to screening and entry.
* Negative HBsAg result obtained within 6 months prior to study entry, or documentation of HBV immunity by positive HBV sAb at any time
* The following laboratory values obtained within 45 days prior to enrollment:
* CD4+ T cell count \>250 cells/ mm\^3
* Absolute neutrophil count (ANC) ≥1000 cells/mm\^3
* Hemoglobin ≥10.0 g/dL for men and ≥9.0 g/dL for women
* Platelet count ≥ 50,000/mm3
* Ability and willingness of participant or legal representative to provide informed consent.
Additional Inclusion Criteria for Step 2 of Study:
* HIV-1 latent reservoir undetectable by co-culture and DNA
* No confirmed detectable HIV-1 RNA \> 1000 cells/mm3 since discontinuation of maraviroc
* Prior HIV-1 genotype results that confirm that there are active agents available in at least three classes of ART drugs (NRTI, NNRTI, PI or integrase).
* Willing to stop ART
* Willing to undergo high volume blood draw (125 cc) at Week 16
* Willing to restart ART if HIV-1 viremia returns
* Provide informed consent for Step 2
Exclusion Criteria:
* Ongoing AIDS-related opportunistic infection (including oral thrush).
* Pregnant and/or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03118661
Study Brief:
Protocol Section:
NCT03118661