Status:
COMPLETED
Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent generalized lymphadenop...
Detailed Description
AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in ...
Eligibility Criteria
Inclusion Criteria
- Detectable HIV nucleic acid in patient peripheral blood mononuclear leukocytes (PBML's) by the gene amplification technique. A positive antibody to HIV confirmed by any federally licensed ELISA test kit.
Concurrent Medication:
Allowed:
- Medications without which there might be significant risk, such as seizures, loss of diabetic control or respiratory embarrassment.
- Necessary topical agents including topical acyclovir.
- Diuretics for significant fluid retention only.
Concurrent Treatment:
Allowed:
- Blood transfusions for anemia if hematocrit falls below 25 percent.
Exclusion Criteria
- Active drug or alcohol abuse.
Co-existing Condition:
Patients with the following will be excluded:
- Grade 1 impairment on two or more items in the ACTG Micro Neuro AIDS assessment.
- Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- Major organ allograft.
- Significant cardiac disease or central nervous system lesions.
- Patients with hemophilia should be evaluated and treated under the hemophilia protocol.
Concurrent Medication:
Excluded:
- Inderal or vasoactive hypertensive medication.
- Non-essential medications including pain medications.
Excluded are:
- Patients with an opportunistic infection or malignancy fulfilling the definition of AIDS.
Patients with AIDS related complex, defined as:
- 1. Weight loss in excess of 15 lbs. or 10 percent of body weight noted in a 2-year period prior to entry into the study. 2. Temperature greater than 38.5 degrees C with or without night sweats, persisting for more than 14 consecutive days or more than 15 days in a 30-day interval during a 2-year period prior to entry into the study. 3. Diarrhea defined as = or > 3 liquid stools per day, persisting for more than 30 days during a 2-year period prior to entry into the study without a definable cause. 4. Herpes zoster during the past 2 years. 5. Oral candidiasis or biopsy-proven hairy leukoplakia during the last 2 years. 6. Active substance abuse.
Prior Medication:
Excluded:
- Zidovudine (AZT).
- Excluded within 30 days of study entry:
- Antiretroviral agents.
- Biologic response modifiers.
- Corticosteroids.
- Excluded within 60 days of study entry:
- Ribavirin.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1990
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00000728
End Date
April 1 1990
Last Update
November 3 2021
Active Locations (1)
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1
Stanford Univ School of Medicine
Stanford, California, United States, 94305