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Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy

NCT00000728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-11-03

No results posted yet for this study

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 lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or toxicity, how quickly the drugs are used in the body, effects on the immune system, effects on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys. The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to determine the dose that has the greatest effect in the immune system.

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.

Conditions

  • HIV Infections

Interventions

DRUG

Zidovudine

DRUG

Aldesleukin

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Merigan TC

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1990-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000728 on ClinicalTrials.gov