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

Tracking Information
First Received Date ^ICMJE	November 3, 2000
Last Updated Date	July 29, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00006443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection
Official Title ^ICMJE	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
Brief 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.
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00006443
Responsible Party
Study ID Numbers ^ICMJE	AIEDRP AI-08-002, PHA 082
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	January 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP