Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006443
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2000-11-03
Brief Title:
Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHA 082 | None | None | None |