Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection

NCT00006443 | Completed

• 2 other identifiers: AIEDRP AI-08-002PHA 082
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare changes in HIV levels and certain immune cells among patients at different stages of HIV infection. This study will also see how a combination of stavudine (d4T), lamivudine (3TC), indinavir (IDV), and nelfinavir (NFV) affects these levels. Current findings in anti-HIV drug treatment have led to a greater understanding of the background of HIV. To find the best anti-HIV treatment to eliminate all HIV viruses, cells and tissues infected with the HIV virus are examined after combination anti-HIV treatment, when the level of HIV infection is low. The ERADICATE study will examine the idea that HIV viruses can be eliminated at any stage of infection over time.

Conditions

HIV Infections

Keywords

T-Lymphocytes; HIV-1; Lymphoid Tissue; Stavudine; HIV Protease Inhibitors; Polymerase Chain Reaction; Biological Markers; Lamivudine; Indinavir; RNA, Viral; Genotype; Phenotype; Cytokines; Nelfinavir; Macrophages; Reverse Transcriptase Inhibitors; In Situ Hybridization; Anti-HIV Agents; Viral Load; Cell Membrane; Acute Infection; Treatment Naive

Interventions

Indinavir sulfate DRUG

Nelfinavir mesylate DRUG

Lamivudine DRUG

Stavudine DRUG

Eligibility Criteria

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

You may qualify if:

• Patients may be eligible for this study if they:
• Are infected with HIV and have had certain tests to indicate the stage of their disease.
• Are at least 18 years old.
• Practice birth control during the study.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Have received anti-HIV medication for more than 1 week.
• Have a serious AIDS-related infection or other illness.
• Require medication that interferes with the study drugs.
• Have had a peripheral neuropathy, a painful condition affecting the nervous system.
• Have been given drugs that affect the immune system within 2 weeks before study entry.
• Have a bleeding disorder including hemophilia.
• Abuse alcohol or substances.
• Are pregnant or breast-feeding.

Sponsors & Collaborators

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

Study Sites (1)

Michael S. Saag

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Nelfinavir; Lamivudine; Stavudine

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 2000
• First Posted: August 31, 2001
• Primary Completion: October 1, 2003
• Last Updated: March 2, 2011

Record last verified: 2005-01

Locations

US (1)