Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087464
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2004-07-08
Brief Title:
Three Month Course of Anti-HIV Medications for People Recently Infected With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Tenofovir Emtricitabine and Nevirapine for Recently HIV-Infected Subjects Can Short-Course Once Daily Therapy Reduce the Viral Load at 12 Months From Estimated Date of Infection
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study was withdrawn before any participants were recruited and enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with HIV The purpose of this study is to see whether it is better for people to take a short course of anti-HIV drugs when they are first infected or if it is better to wait until the HIV infection causes health problems before taking anti-HIV drugs
Detailed Description:
Limited access to HIV treatment is a major problem in many parts of the world If a well tolerated anti-HIV regimen with convenient once-daily dosing is effective in reducing viral load in people with recent or early HIV infection this regimen could be used globally for controlling HIV This study will determine the effectiveness of a three-month antiretroviral regimen in reducing viral load in HIV infected adults who were recently infected or have recently seroconverted This study will recruit participants from Alabama and Tennessee in the United States and in Lusaka Zambia
Participants in this study must also be enrolled in the AIEDRP CORE01 study Participants in this study will be divided into Early and Acute groups Participants in the Early group will be people who have recently seroconverted participants in the Acute group will be people with primary HIV infection All participants will choose to receive the once-daily dosing regimen of emtricitabine nevirapine and tenofovir disoproxil fumarate Didanosine efavirenz and stavudine may be substituted for other drugs in the regimen at the investigators discretion Participants will take the three-drug regimen for 90 days If a participants CD4 count is higher than 350 cellsmm3 at Day 90 the participant will stop therapy If a participants CD4 count is 350 cellsmm3 or lower at Day 90 or if the participants CD4 count drops to 350 cellsmm3 or lower while therapy is stopped the participant will receive an additional 30 days of therapy This therapy strategy may be repeated as necessary up to Day 180 All participants taking the three-drug regimen will be followed regardless of whether or not they have taken the regimen beyond Day 90
In addition to AIEDRP CORE01s study visits 7 additional study visits will occur at pretreatment on Day 3 and at Weeks 1 3 8 16 and 20 Blood collection will occur at all study visits Data from study participants will be compared with data from a historical cohort of previously identified HIV infected adults with acute or early infection who did not receive treatment but were followed prospectively
Participants in this study must also be enrolled in the AIEDRP CORE01 study Participants in this study will be divided into Early and Acute groups Participants in the Early group will be people who have recently seroconverted participants in the Acute group will be people with primary HIV infection All participants will choose to receive the once-daily dosing regimen of emtricitabine nevirapine and tenofovir disoproxil fumarate Didanosine efavirenz and stavudine may be substituted for other drugs in the regimen at the investigators discretion Participants will take the three-drug regimen for 90 days If a participants CD4 count is higher than 350 cellsmm3 at Day 90 the participant will stop therapy If a participants CD4 count is 350 cellsmm3 or lower at Day 90 or if the participants CD4 count drops to 350 cellsmm3 or lower while therapy is stopped the participant will receive an additional 30 days of therapy This therapy strategy may be repeated as necessary up to Day 180 All participants taking the three-drug regimen will be followed regardless of whether or not they have taken the regimen beyond Day 90
In addition to AIEDRP CORE01s study visits 7 additional study visits will occur at pretreatment on Day 3 and at Weeks 1 3 8 16 and 20 Blood collection will occur at all study visits Data from study participants will be compared with data from a historical cohort of previously identified HIV infected adults with acute or early infection who did not receive treatment but were followed prospectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AIEDRP AI-08-005 | Registry Identifier | DAIDS ES | None |
| 11534 | REGISTRY | None | None |