Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00007202
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Pilot Open-Label Phase II Clinical Trial to Evaluate the Safety and Efficacy of a Compact Three Drug Antiretroviral Treatment Regimen for Subjects With Acute HIV-1 Infection or Recent HIV-1 Seroconversion
Status:
COMPLETED
Status Verified Date:
2021-10
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 determine the safety and effectiveness of stavudine (d4T), didanosine (ddI), and BMS-232632 when given early in the course of HIV infection.
Acute HIV infection may develop in patients that are exposed to the HIV virus. Following infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to weeks. It is not known which is the best treatment in patients with very early HIV infection. Researchers believe these patients may respond well to strong early treatment. A combination consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632, will be tested.
Acute HIV infection may develop in patients that are exposed to the HIV virus. Following infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to weeks. It is not known which is the best treatment in patients with very early HIV infection. Researchers believe these patients may respond well to strong early treatment. A combination consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632, will be tested.
Detailed Description:
Acute primary HIV-1 infection (PHI) follows exposure to the HIV-1 virus and results in a rapid rise in plasma viremia within days to 1 to 3 weeks. Individuals with acute PHI or early HIV-1 infection represent a potentially unique patient population in which to evaluate potent antiretroviral therapies because of the degree of viral heterogeneity and the fact that immunologic disruption is likely to be lower than in later stages of HIV-1 disease. The optimal treatment for acute PHI is unknown. This study evaluates a regimen consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632.
Patients are enrolled into Group I or Group II and may participate in substudies. Patients in Group I receive ddI-EC, d4T, and BMS-232632 daily for 52 weeks. Clinical, virologic, and immunologic evaluations are performed on Days 2, 7, 14, 21, and 28, then every 4 weeks through Week 24, and then every 8 weeks thereafter through Week 48. Based on laboratory results from the Week 48 visit, a decision is made by Week 52 whether or not to continue study medications for an additional 52 weeks. Evaluation schedules for those patients enrolled in substudies may be different. Group II patients elect not to receive antiretroviral treatment and are followed as a natural history disease group to be compared with patients in Group I. They are followed according to the same schedule of evaluations as those enrolled in Group I, unless otherwise specified as part of their participation in substudies. All patients are followed in this study at 8-week intervals for a total duration of 104 weeks (2 years). HIV will be measured in plasma and tissues to determine reduction in replication for a duration of at least 48 weeks.
The 3 substudies in which patients may participate are AI-03-006, Lymphoid Tissue Substudy; AI-03-007, Immunology Substudy of cytolytic and co-stimulatory markers, T-cell repertoire, and cytokine and chemokine elaboration; and AI-03-008, Viral Dynamics and Diversity Substudy.
Patients are enrolled into Group I or Group II and may participate in substudies. Patients in Group I receive ddI-EC, d4T, and BMS-232632 daily for 52 weeks. Clinical, virologic, and immunologic evaluations are performed on Days 2, 7, 14, 21, and 28, then every 4 weeks through Week 24, and then every 8 weeks thereafter through Week 48. Based on laboratory results from the Week 48 visit, a decision is made by Week 52 whether or not to continue study medications for an additional 52 weeks. Evaluation schedules for those patients enrolled in substudies may be different. Group II patients elect not to receive antiretroviral treatment and are followed as a natural history disease group to be compared with patients in Group I. They are followed according to the same schedule of evaluations as those enrolled in Group I, unless otherwise specified as part of their participation in substudies. All patients are followed in this study at 8-week intervals for a total duration of 104 weeks (2 years). HIV will be measured in plasma and tissues to determine reduction in replication for a duration of at least 48 weeks.
The 3 substudies in which patients may participate are AI-03-006, Lymphoid Tissue Substudy; AI-03-007, Immunology Substudy of cytolytic and co-stimulatory markers, T-cell repertoire, and cytokine and chemokine elaboration; and AI-03-008, Viral Dynamics and Diversity Substudy.
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?: