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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006443
First received: November 3, 2000
Last updated: March 1, 2011
Last verified: January 2005
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Nelfinavir mesylate
Drug: Lamivudine
Drug: Stavudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluating Responses to Antiretroviral Drugs in Cells and Tissues (The ERADICATE Study): Comprehensive Comparisons of Viral and Cellular Dynamics Among Previously-Untreated Subjects With Acute HIV Infection (Seroconversion Syndrome) or Recently Acquired HIV Infection Versus the Early, Middle, and Advanced Stages of Seropositive HIV Infection

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Detailed Description:

Recent advancements in antiretroviral therapy have led to a better understanding of the natural history and immunopathogenesis of HIV-1 infection. To calculate the degree and duration of antiretroviral effect necessary to eliminate infection, characterization of residual cellular and tissue HIV reservoirs following high-level viral suppression is necessary. The ERADICATE study will evaluate the hypothesis that complete viral inhibition is possible, regardless of HIV disease stage, and leads to HIV eradication from tissues over time.

Patients are divided into 1 of 5 groups based on the stage of HIV infection. Patients receive oral stavudine (d4T), lamivudine (3TC), indinavir (IDV), and nelfinavir (NFV) twice daily for 24 weeks. All patients undergo basic blood sampling to follow HIV-1 RNA levels and absolute T cell subset numbers daily for 5 days; then 3 times a week for 3 weeks; 2 times a week for 4 weeks; every 2 weeks for 12 weeks; and monthly thereafter for a total of 3 years. In addition, the following tissues are sampled at baseline and after 2 weeks and 6 months on therapy: 1) lymph node; 2) tonsillar; 3) perirectal lymphoid; 4) cerebrospinal fluid; 5) and semen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006443

Locations
United States, Alabama
Michael S. Saag
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006443     History of Changes
Other Study ID Numbers: AIEDRP AI-08-002, PHA 082
Study First Received: November 3, 2000
Last Updated: March 1, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Indinavir
Nelfinavir
Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014