Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006339
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2000-10-04
Brief Title:
Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Randomized Open-Label Clinical Trial to Evaluate the Comparative Efficacy and Safety of a Potent Antiretroviral Treatment Regimen With or Without Hydroxyurea for Subjects With Acute HIV-1 Infection or Recent HIV-1 Seroconversion
Status:
WITHDRAWN
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 compare the safety and effectiveness of an anti-HIV drug combination with and without hydroxyurea in patients with early HIV infection
Certain combinations of anti-HIV drugs have been effective in lowering levels of HIV in the blood and keeping them down However these treatments are not effective in some patients This study will see if using a combination containing more drugs will help in patients with early HIV infection
Certain combinations of anti-HIV drugs have been effective in lowering levels of HIV in the blood and keeping them down However these treatments are not effective in some patients This study will see if using a combination containing more drugs will help in patients with early HIV infection
Detailed Description:
Combination antiretroviral therapy including two nucleoside reverse transcriptase inhibitors NRTIs and a single HIV-1 protease inhibitor PI results in significant and sustained decreases in plasma HIV-1 RNA with a resultant marked diminution in the selection of drug-resistant variants in those able to adhere to and tolerate these regimens However two lines of evidence suggest that additional and perhaps more aggressive approaches may be necessary in some HIV-infected individuals 1 the failure of some potent three-drug regimens to sustain viral replication to levels below the limits of detection and 2 the ability to recover virus from lymphoid tissue obtained from those without evidence of detectable plasma HIV-1 RNA using the most sensitive assays A regimen containing more drugs with potentially different mechanisms of action or synergistic activity may result in greater more rapid or more durable antiviral activity or reduce the number of latently infected cells in those patients with acute or early HIV-1 infection
Patients in Group I begin study therapy within 7 to 14 days of screening Patients are randomized to 1 of 2 treatment arms Arm A receives stavudine d4T plus didanosine ddI plus ritonavir plus indinavir Arm B receives d4T plus ddI plus ritonavir plus indinavir plus hydroxyurea Patients are discontinued from hydroxyurea after Week 24 Group II consists of patients who meet eligibility criteria but who elect not to receive antiretroviral treatment Patients in Groups I and II follow the same schedule of evaluations Enrollment visit Week 0 evaluations are completed prior to dispensing drugs and all patients have clinical virologic and immunologic evaluations performed every 4 weeks through Week 24 then every 8 weeks thereafter Patients in Group I take study drugs for 104 weeks with an optional 52-week rollover Laboratory results from the Week 96 evaluation are used to decide whether or not patients continue on study medications Patients who elect not to participate in the optional rollover or meet criteria for treatment failure at any time during the study are offered the best available treatment at the discretion of their HIV care provider and continue to be followed at 8-week intervals
Patients in Group I begin study therapy within 7 to 14 days of screening Patients are randomized to 1 of 2 treatment arms Arm A receives stavudine d4T plus didanosine ddI plus ritonavir plus indinavir Arm B receives d4T plus ddI plus ritonavir plus indinavir plus hydroxyurea Patients are discontinued from hydroxyurea after Week 24 Group II consists of patients who meet eligibility criteria but who elect not to receive antiretroviral treatment Patients in Groups I and II follow the same schedule of evaluations Enrollment visit Week 0 evaluations are completed prior to dispensing drugs and all patients have clinical virologic and immunologic evaluations performed every 4 weeks through Week 24 then every 8 weeks thereafter Patients in Group I take study drugs for 104 weeks with an optional 52-week rollover Laboratory results from the Week 96 evaluation are used to decide whether or not patients continue on study medications Patients who elect not to participate in the optional rollover or meet criteria for treatment failure at any time during the study are offered the best available treatment at the discretion of their HIV care provider and continue to be followed at 8-week intervals
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 |
|---|---|---|---|
| Substudy AI-03-004 | Registry Identifier | DAIDS ES | None |
| 11508 | REGISTRY | None | None |
| AIEDRP AI-03-001 | None | None | None |
| Substudy AI-03-002 | None | None | None |
| Substudy AI-03-003 | None | None | None |