Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
Aldesleukin
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit. Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.78 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Patients must have: HIV positivity. CD4 count >= 500 cells/mm3. No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma. Concurrent Medication: Required: Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T). Prior Medication: Required: FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant cardiac, pulmonary, thyroid, renal, or CNS disease. Prior Medication: Excluded: Prior IL-2. Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, United StatesOpen Natl Inst of Allergy & Infect Dis / Cln Ctr in Google Maps