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Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection
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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 |
| Estimated Enrollment: | 24 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00006443
| United States, Alabama | |
| Michael S. Saag | |
| Birmingham, Alabama, United States, 35294 | |
More Information
| 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 |
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:
|
Infection Communicable Diseases 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 Indinavir |
Nelfinavir Lamivudine Stavudine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites |
ClinicalTrials.gov processed this record on June 23, 2017