Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006617
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2000-12-06
Brief Title:
Four-Drug Combination Therapy With Zidovudine Lamivudine 1592U89 Abacavir and 141W94 Amprenavir in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy Zidovudine EPIVIR 1592U89 and 141W94 in Subjects Infected With HIV-1 GW QUAD
Status:
COMPLETED
Status Verified Date:
2004-12
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 see if the multidrug combination of zidovudine ZDV lamivudine 3TC 1592U89 abacavir ABC and 141W94 amprenavir APV is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues
HIV infection is a life-changing illness and new HIV treatments must be tested This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period
HIV infection is a life-changing illness and new HIV treatments must be tested This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period
Detailed Description:
With effective combination ART there is a decrease in HIV-1 RNA in plasma after 2 to 3 weeks A second slower phase of viral decay is thought to occur in long-lived macrophages with a minimal contribution from lymphocytes This study addresses whether there is a third reservoir such as the central nervous system Additionally the study aims to provide a better understanding of the type and length of ART required to suppress HIV-1 replication in multiple reservoirs
Patients receive treatment with ZDV 3TC ABC and APV daily for 24 weeks Clinic visits occur weekly until Week 4 then every 2 weeks until Week 12 then monthly Blood and urine samples are collected and patients are monitored for clinical or laboratory abnormalities Laboratory tests to assess side effects and virologic and immunologic parameters including viral quantification of CSF on all chronically infected patients and selected consenting acutely infected patients are determined In a pharmacoeconomic component of this study patients have interviews and complete questionnaires at 5 clinic visits
Patients receive treatment with ZDV 3TC ABC and APV daily for 24 weeks Clinic visits occur weekly until Week 4 then every 2 weeks until Week 12 then monthly Blood and urine samples are collected and patients are monitored for clinical or laboratory abnormalities Laboratory tests to assess side effects and virologic and immunologic parameters including viral quantification of CSF on all chronically infected patients and selected consenting acutely infected patients are determined In a pharmacoeconomic component of this study patients have interviews and complete questionnaires at 5 clinic visits
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 |
|---|---|---|---|
| AIEDRP AI-04-008 | None | None | None |
| PROA2003 | None | None | None |