A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Detailed Description

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Patients will receive subcutaneous Proleukin, and the MTD will be determined.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Aldesleukin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* Documented HIV infection by ELISA and Western blot.
* CD4 count \> 200 cells/mm3.

Required:

* FDA-approved antiretroviral therapy for at least 2 months prior to study entry.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Davies Med Ctr / c/o HIV Institute

San Francisco, California, United States

Site Status

Countries

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United States

References

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Follansbee SE, Lacarrubba S, Fyfe G. Dose-ranging study of interleukin II (IL-2) in HIV-infected men on antiretroviral therapy (ARV). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:142 (abstract no 419)

Reference Type BACKGROUND

Other Identifiers

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CS-L293-09

Identifier Type: -

Identifier Source: secondary_id

085A