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OpenTrials
Completed

NCT Number: NCT00006443

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael S. Saag

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indinavir sulfate

Drug

nelfinavir mesylate

Drug

Lamivudine

Drug

Stavudine

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study 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

Important dates

Primary completion
2003
First posted
Aug 31, 2001
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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