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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT00842634
Eligibility Criteria:
Inclusion Criteria:
Cohort 1 Only:
* Patients who have been on two more HAART regimens and have failed due to resistance or tolerance (no changes to treatment within 4 weeks of study entry), and who have no viable treatment options likely to result in complete viral suppression.
* CD4+ T cell count of ≥200 cells/mm3
* HIV-1 RNA ≥2000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay.
* Two HIV-1 RNA levels \<150,000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay. These HIV-1 RNA measurements must be at least 48 hours apart and may include the HIV-1 RNA measurement done at the time of the screening visit.
* Ongoing treatment with HIV entry inhibitors such as enfurvitide or maraviroc are excluded
Cohort 2 Only:
* On a stable antiretroviral medication (no changes to treatment within 4 weeks of study entry) and be willing to continue on current antiretroviral therapy for the duration of the study until undergoing structured treatment interruption.
* CD4+ T cell count of ≥450 cells/mm3 at screen; and a documented CD4 nadir of not lower than 300 cells/mm.
* HIV-1 RNA undetectable by ultrasensitive HIV PCR assay obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay.
Cohort 3 only:
* On a stable antiretroviral medication (no changes to treatment within 4 weeks of study entry) and be willing to continue on current antiretroviral therapy for the duration of the study.
* CD4+ T cell count that is persistently \<500 cells/mm3 despite at least 2 years of stable HAART and \>200 cells/mm3 at screen
* Subjects must have received at least 2 continuous years of therapy and have had undetectable viral loads by ultrasensitive assay since 6 months of therapy. Subjects who have had a single viral load blip at any point in this time, or who experience intermittent isolated episodes of detectable low-level viremia (detectable but \<1000 copies RNA/mL; blips) will remain eligible.
* Subjects who are currently taking maraviroc or have received maraviroc within 6 months of study entry are excluded.
Inclusion for Cohort 1, Cohort 2, Cohort 3:
* HIV-1 infection, as documented by ELISA and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
* Adequate venous access and no other contraindications for leukapheresis.
* Laboratory values obtained at screen. Hemoglobin: ≥ 10.0 (males); ≥ 9.5 (females) g/dL Absolute neutrophil count (ANC): ≥ 1000/mm3 Platelet count: ≥ 100,000/mm3 Serum creatinine: ≤ 1.5 mg/dL (133µ mol/L) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT): ≤ 2.5 times the upper limit of normal (ULN).
* Subjects must be willing to comply with study-mandated evaluations; including not changing their antiretroviral regimen (unless medically indicated) for 2 months in step 2 (Cohort 1) or until undergoing structured treatment interruption (Cohort 2).
* Karnofsky Performance Score of 70 or higher
Exclusion Criteria:
* Acute or chronic hepatitis B or hepatitis C infection
* Current or prior AIDS diagnosis (Cohort 1 and 2 only)
* History of cancer or malignancy, (basal cell or squamous cell carcinoma of the skin allowed)
* History or problems with uncontrolled heart disease, bleeding or hemodynamic instability.
* Have been previously treated with any HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
* Use of the following medications within the last 30 days: chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.)
* Breast-feeding, pregnant, or unwilling to use acceptable methods of birth control.
* Use of aspirin, dyprydamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2-week period prior to leukapheresis.
* Active drug or alcohol use or dependence that in the opinion of the investigator, would interfere with adherence to study requirements
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
* Receipt of a vaccination within 30 days prior to study entry.
* Have an allergy or hypersensitivity to study product excipients (human serum albumin, DMSO and Dextran 40).
* Currently taking medications called HIV entry inhibitors such as enfuvirtide or maraviroc
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00842634
Study Brief:
Protocol Section:
NCT00842634