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Completed Phase 1 Interventional

A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients With CD4 Cell Counts Less Than 50 Cells/mm3 or 300-500 Cells/mm3

ClinicalTrials.gov ID: NCT00000857

Public ClinicalTrials.gov record NCT00000857. 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 Nov 6, 2026, 4:40 AM EST

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Official title

A Phase I, Double-Blind, Randomized, Placebo-Controlled Trial of Recombinant Human Interleukin-12 (rhIL-12) in HIV-Infected Subjects With Less Than 50 CD4+ T Cells and Subjects With 300-500 CD4+ T Cells

Brief summary

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

The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3. This study will look at the ability of rhIL-12 to boost the immune system against HIV and HIV-associated bacterial infections in these patients. IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection. IL-12 may also increase the body's ability to fight bacterial infections such as Mycobacterium avium complex (MAC).

Study identification

NCT ID
NCT00000857
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
65 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 60 Years
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
Jun 2001 (Actual)
Last update posted
Oct 29, 2021

Ends 2001

United States locations

U.S. sites
16
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
UCLA CARE Center CRS Los Angeles California 90095 —
USC CRS Los Angeles California — —
Stanford CRS Palo Alto California — —
Ucsf Aids Crs San Francisco California — —
Harbor-UCLA Med. Ctr. CRS Torrance California 90502 —
Northwestern University CRS Chicago Illinois 60611 —
Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois 60612 —
Weiss Memorial Hosp. Chicago Illinois 60640 —
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana — —
Massachusetts General Hospital ACTG CRS Boston Massachusetts 02114 —
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts 02215 —
NY Univ. HIV/AIDS CRS New York New York 10016 —
Univ. of Rochester ACTG CRS Rochester New York 14642 —
Unc Aids Crs Chapel Hill North Carolina — —
Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania 19104 —
University of Washington AIDS CRS Seattle Washington 98104 —

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 NCT00000857, 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 Oct 29, 2021 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00000857 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →