Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
Interleukin-2, Polyethylene Glycolated
+ Zidovudine
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone. Four groups are studied for a period of at least 25 weeks. Patients are observed for a minimum of 6 hours after infusion of PEG IL2. The 4 groups of patients are: Group A - asymptomatic with T4 count > 400 cells/mm3 (7 patients); Group B - asymptomatic with T4 count between 200 and 400 cells/mm3 (7 patients); Group C - asymptomatic with T4 count < 200 cells/mm3 (5 patients); Group D - diagnosed as having AIDS related complex (ARC) or AIDS (7 patients). All patients receive AZT. After a minimum 2-week period of AZT, patients receive an infusion of PEG IL-2 at 3 consecutive weekly intervals, followed by a 3-week period of AZT alone. This cycle (3 weeks of AZT and PEG IL-2 followed by 3 weeks of AZT alone) is repeated a total of three times (for a total of 18 weeks) followed by 8 weeks of AZT alone. PER AMENDMENT: Ten patients may qualify for one of two groups: Group 1 - T4 count 200 - 400 cells/mm3 and meet all criteria established for Group B of the original protocol; Group 2 - T4 count < 200 cells/mm3 and meet all criteria established for Groups C and D of original protocol. Patients will receive an amended schedule of PEG IL2 IV every other week for eight doses, with dose escalation every other week for eight weeks permitted only in Group 2 patients who failed to show a 20 percent rise in T4 count at week 9 and who suffered no CNS or other adverse events at the lower dose. PER ADDITIONAL AMENDMENT: Up to 10 additional patients may be treated at each dose of PEG IL2 on the biweekly schedule. Patients who respond to treatment on the biweekly schedule are eligible for an additional 9 weeks at their current dose.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 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 Concurrent Medication: Allowed: Prophylactic pentamidine for Pneumocystis carinii pneumonia (PCP). Topical steroids. Patients must: Be HIV positive. Fit one of the zidovudine use groups listed in Disease Status. Be able to give informed consent. Allowed: Basal cell carcinoma of the skin, in situ carcinoma of the cervix, Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Major organ allograft. Significant cardiac disease or central nervous system lesions. Known previous intolerance to zidovudine (AZT) at 500 mg/day. Active opportunistic infections. Score of > 0.5 on the ACTG AIDS dementia complex staging test. Any focal abnormality on neurologic exam. Concurrent Medication: Excluded: Chemotherapy, hormonal therapy, or other immunotherapy. Other investigational drugs, agents, or devices. Beta-blockers. Steroids other than topical. Antihypertensive medication other than diuretics. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following are excluded: History of seizures. Concurrent neoplasms not specifically allowed. Concomitant conditions listed in Exclusion Co-existing Conditions. Prior Medication: Excluded within 30 days prior to study entry: Anti-HIV medication other than zidovudine (AZT). Immunomodulators. Systemic steroids. Interferons. Interleukins. Other chemotherapy. Prior Treatment: Excluded within 30 days prior to study entry: Radiation therapy. Excluded within 4 weeks prior to study entry: Groups B, C, D Transfusions. Active substance abuse.
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