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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00000728

Public ClinicalTrials.gov record NCT00000728. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 9:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00000728
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
20 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Mar 31, 1990
Last update posted
Nov 2, 2021

Ends 1990

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Stanford Univ School of Medicine Stanford California 94305

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000728, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2021 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000728 live on ClinicalTrials.gov.

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