Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy
Data Collection
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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 treating Kaposi's sarcoma in a number of patients. Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap, it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects. Patients enter the study in staggered groups of five. All patients receive AZT orally every 4 hours for 12 weeks. At the end of 8 weeks, the first group of five patients receive the lowest dosage of IL-2 on a daily basis while still receiving AZT. Toxicity and immunologic effects are measured at the beginning of AZT therapy and then every 2 weeks. Each succeeding group of five patients receives a higher dose of IL-2, while receiving AZT, until the MTD is reached. Those patients who have shown no toxicity as well as improved immune function while taking both drugs receive a 4-week follow-up course of IL-2 5 weeks after stopping AZT. In addition, five patients who have completed the AZT / IL-2 combined treatment without significant toxicity are re-treated with 12 weeks of AZT alone starting 8 weeks after completing the initial combined AZT / IL-2 portion of treatment. Another five patients will be re-treated with 12 weeks of full dose of AZT alone, followed by 8 weeks of half-dose AZT alone starting 8 weeks after completing the initial combined AZT / IL-2 treatment. Patients receive ibuprofen for fever and chills, and those who reach their MTD continue to receive that dose in combination with AZT for 4 weeks. If excess toxicity is observed on all doses of IL-2, the study will be discontinued.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 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 * 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.
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
Stanford Univ School of Medicine
Stanford, United StatesOpen Stanford Univ School of Medicine in Google Maps