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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006443
• Other study ID #: AIEDRP AI-08-002
• Secondary ID: PHA 082
• Status: Completed
• Phase: N/A
• First received: November 3, 2000
• Last updated: March 1, 2011

Study information

• Verified date: January 2005
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• Indinavir sulfate

• Nelfinavir mesylate

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
United States	Michael S. Saag	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

External Links

•   Click here for more information about indinavir sulfate
•   Click here for more information about lamivudine
•   Click here for more information about nelfinavir mesylate
•   Click here for more information about stavudine
•   Haga clic aquí para ver información sobre este ensayo clínico en español.