A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients

NCT00000896 | Completed

• 2 other identifiers: ACTG 38711346
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to examine how the level of HIV is reduced in the blood when anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12 to the anti-HIV drug regimen will increase the rate that HIV is reduced. The anti-HIV drugs used in this study will include lamivudine (3TC), zidovudine (ZDV), indinavir (IDV), nevirapine (NVP), and stavudine (d4T). All have been used successfully to treat HIV. GM-CSF has been used to treat certain blood disorders; it will be used as an experimental drug in this study. IL-12 (interleukin-12) is a protein found naturally in the body that is thought to boost the immune system. Although GM-CSF and IL-12 have no direct effect against HIV, these drugs may improve the ability of the immune system to fight the virus.

Conditions

HIV Infections

Keywords

HIV-1; Drug Therapy, Combination; Granulocyte Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; Zidovudine; Nevirapine; Stavudine; HIV Protease Inhibitors; Lamivudine; Indinavir; Interleukin-12; Reverse Transcriptase Inhibitors

Interventions

Indinavir sulfate DRUG

Lamivudine/Zidovudine DRUG

Hepatitis A Vaccine (Inactivated) BIOLOGICAL

Interleukin-12 DRUG

Nevirapine DRUG

Stavudine DRUG

Sargramostim DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• You may be eligible for this study if you:
• Are HIV-positive.
• Have a CD4 cell count greater than or equal to 300 cells/ml within 30 days prior to study entry.
• Have a plasma viral load (level of HIV in the blood) of greater than or equal to 20,000 copies/ml within 30 days of study entry.
• Are at least 18 years old.
• Agree to practice abstinence or use effective methods of birth control during the study.

You may not qualify if:

• You will not be eligible for this study if you:
• Have taken anti-HIV medication for more than 7 days.
• Have had known seroconversion within 6 months prior to study entry.
• Have any infection requiring treatment within 30 days prior to study entry.
• Have had a fever for 7 days in a row during the 30 days before study entry.
• Have cancer that requires chemotherapy.
• Are pregnant or breast-feeding.
• Are taking certain medications.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

Ucsd, Avrc Crs

San Diego, California, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Indinavir; lamivudine, zidovudine drug combination; Hepatitis A Vaccines; Interleukin-12; Nevirapine; Stavudine; sargramostim

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Rhonda G. Kost

  STUDY CHAIR

• David Ho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 2000
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (3)