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 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00145795
Eligibility Criteria:
Inclusion Criteria:
* HIV Infection documented CD4+ count within the last 30 days (or drawn with screening labs)
* Currently on a stable 3-drug HAART regimen including 2 NRTIs for \> 6 month viral load (VL) \< 50/mm3 for \> 6 months, last within the last 30 days (or drawn with screening labs)
* Partial immune responder or immune non-responder
* Age \> 18 years
* Labs (drawn at screening)
* Alanine transaminase (ALT) \< 5 X the upper limit of normal (ULN)
* Total bili \< 2 X ULN
* Creatinine \< 2.0 mg/dL
Exclusion Criteria:
* Prior therapy with Kaletra
* Known hypersensitivity to Ritonavir
* Therapy the drugs with potential serious drug interactions: flecainide, propafenone, astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, lovastatin, simvastatin, midazolam, triazolam, and St. John's wart.
* Pregnancy; breast feeding
* Current malignancy requiring CT
* Use of systemic corticosteroids, immunosuppressive, or cytotoxic agents within the last 45 days
* Fever and/or evidence of an active infectious complication
* Currently in another interventional clinical trial
* Receiving Interleukin-2 (IL-2) or any other cytokine or growth factor
* Enrollment in another interventional clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00145795
Study Brief:
Protocol Section:
NCT00145795