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 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT02990312
Eligibility Criteria:
Inclusion Criteria:
1. Patient is able to understand and provide informed consent and comply with the study protocol
2. Diagnosis of HIV infection based on medical record documentation, ELISA and western blot testing, or a record of a detectable HIV viral load
3. Participant is \> or = 18 years
4. CD4 T cell count \> or = 200 cells per microliter within 16 weeks prior to enrollment
5. Most recent HIV-1 RNA \< 50 copies per milliliter within 16 weeks prior to enrollment
6. Participant must be \> or = 6 months post-renal transplant
7. GFR \>25 for a minimum of 6 months prior to enrollment
8. On a maintenance immunosuppressive regimen for a minimum of 6 months prior to enrollment
9. Female participants of child bearing age must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test within 30 days of enrollment and agree to use contraception during the study
Exclusion Criteria:
1. Proteinuria at screening defined by spot urine protein to creatinine ratio \>1000 milligrams per gram
2. The following active opportunistic infections: Ongoing chronic infections such as progressive multifocal leukoencephalopathy (PML), disseminated cryptococcosis, chronic cryptosporidiosis
3. Active malignancy other than superficial skin neoplasms, vulvar intraepithelial neoplasia (VIN), cervical intraepithelial neoplasia (CIN), or anal intraepithelial neoplasia (AIN)
4. Any history of augmented immunosuppression with induction immunosuppression regimens for the treatment of rejection in the 6 months prior to enrollment
5. Known allergy or intolerance to maraviroc or sirolimus
6. Pregnancy or breastfeeding
7. Active substance abuse or mental health concerns that are judged to place a significant limitation on medication adherence by the PI.
8. Triglyceride elevation at screening \> 750; or LDL-c \> 160 despite medical treatment
9. Use of any investigational drugs within 30 days prior to screening
10. History of serious adverse reactions to macrolide antibiotics, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and abdominal pain.
11. Past or current medical problems not listed above which, at the discretion of the investigator, may pose additional risks from participation in the study, interfere with the participants ability to comply with study requirements or impact the quality or interpretation of data obtained from the study
12. Known contraindication to the use of maraviroc or sirolimus
13. Current and ongoing need for concomitant use of rifampin, rifabutin, rifapentine, St. John's wort, phenytoin, phenobarbital, carbamazepine or dofetilide
14. Any current incompletely healed wounds
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02990312
Study Brief:
Protocol Section:
NCT02990312