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Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients



Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers. 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 78

Location and Contact Information:

Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  IL-2 SC;  IRP 015,93-I-0205
Study Start Date: 
Record last reviewed: August 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000821

Other Hiv Infections Studies:
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3. A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

4. The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

5. An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects with HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen

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