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

Condition(s) targeted: HIV Infections

Intervention: Indinavir sulfate (Drug); Nelfinavir mesylate (Drug); Lamivudine (Drug); Stavudine (Drug)

Phase: N/A

Status: Completed

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

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.

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

Study design: Interventional, Treatment

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.

Minimum age: 18 Years. Gender(s): Both.

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.

Michael S. Saag, Birmingham, Alabama 35294, United States

Click here for more information about stavudine

Click here for more information about lamivudine

Click here for more information about indinavir sulfate

Click here for more information about nelfinavir mesylate

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Last updated: June 23, 2005