Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000820 |
PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone.
SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines.
The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Aldesleukin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy |
Estimated Enrollment: | 104 |
The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Patients are randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks, after which each group is crossed over to the other treatment assignment (i.e., IL-2 is either added or deleted from the regimen) for an additional 24 weeks. Patients who are vaccine eligible receive influenza, tetanus and diphtheria toxoid, and meningococcal polysaccharide vaccines at week 4, and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Prior Medication: Required:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Active alcohol or substance abuse that would compromise study compliance.
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Connecticut | |
Yale Univ / New Haven | |
New Haven, Connecticut, United States, 065102483 | |
United States, District of Columbia | |
George Washington Univ / Hershey Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Louisiana | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Univ of Pennsylvania at Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Thomas Jefferson Univ Hosp | |
Philadelphia, Pennsylvania, United States, 191075098 | |
United States, Texas | |
Univ of Texas Galveston | |
Galveston, Texas, United States, 775550435 |
Study Chair: | Teppler H | |
Study Chair: | Pomerantz R |
Study ID Numbers: | ACTG 248 |
Study First Received: | November 2, 1999 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00000820 |
Health Authority: | United States: Federal Government |
Interleukin-2 Drug Therapy, Combination AIDS-Related Complex Antiviral Agents |
Virus Diseases Sexually Transmitted Diseases, Viral Aldesleukin Interleukin-2 HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Infection Antiviral Agents |
Pharmacologic Actions Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lentivirus Infections Analgesics Peripheral Nervous System Agents Central Nervous System Agents |