Completed

A Phase I/II Study of the Combination of Azidothymidine and Interleukin-2 (IL-2) in the Treatment of HIV-Infected Patients

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What is being tested

Zidovudine (AZT) & Interleukin-2 (IL2)

Drug

Who is being recruted

HIV Infection

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 1991

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: March 4, 2008

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Study start date: July 1, 1991Actual date on which the first participant was enrolled.

This study will evaluate the long-term toxicity and obtain preliminary information about long-term efficacy of the combination of antiretroviral therapies and interleukin-2 (IL-2), a cytokine with immunomodulatory properties. Currently 73 patients have been approved to receive IL-2 at a starting dose of 18 MIU/d for 5 days. Multiple courses of IL-2 will be administered, at approximately 2 month intervals. Clinical, laboratory, immunologic, and viral parameters will be closely monitored during this time for evidence of toxicity and preliminary evidence of efficacy. This study will evaluate the long-term toxicity and obtain preliminary information about long-term efficacy of the combination of antiretroviral therapies and interleukin-2 (IL-2), a cytokine with immunomodulatory properties. Currently 73 patients have been approved to receive IL-2 at a starting dose of 18 MIU/d for 5 days. Multiple courses of IL-2 will be administered, at approximately 2 month intervals. Clinical, laboratory, immunologic, and viral parameters will be closely monitored during this time for evidence of toxicity and preliminary evidence of efficacy.

Official TitleA Phase I/II Study of the Combination of Azidothymidine and Interleukin-2 (IL-2) in the Treatment of HIV-Infected Patients

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: March 4, 2008

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

73 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sexBiological sex of participants that are eligible to enroll.

Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HIV Infection

Criteria

No eligibility criteria are available at this time.Please check with the study contact for more details.

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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

Suspended

National Institute of Allergy and Infectious Diseases (NIAID)Bethesda, United StatesSee the location

CompletedOne Study Center