Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050895
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-12-30
Brief Title:
Comparing the Safety Effectiveness and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Open-Label Comparison of LopinavirRitonavir Plus Efavirenz Versus LopinavirRitonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection
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:
With new strategies and drugs available many different regimens exist for the treatment of HIV The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection
Detailed Description:
Numerous treatment options are available to HIV infected patients who are antiretroviral ARV therapy naive but an optimal regimen has not yet been established This study will compare a nonnucleoside reverse transcriptase inhibitor NNRTI-based regimen a ritonavir RTV-enhanced protease inhibitor PI-based regimen and a nucleoside reverse transcriptase inhibitor NRTI-sparing regimen for the initial treatment of HIV infection
Patients will be randomly assigned to one of three study arms In Arm A patients will receive lopinavirritonavir LPVr twice daily and efavirenz EFV once daily before bed Arm B patients will receive LPVr twice daily lamivudine 3TC once daily plus either stavudine extended release d4T XR once daily zidovudine ZDV twice daily or tenofovir disoproxil fumarate TDF once daily Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed ZDV twice daily or TDF once daily before bed
Study visits will occur every 4 weeks until Week 24 then every 8 weeks thereafter for a maximum of 96 weeks Blood will be drawn at every visit and a urine sample will be collected every 8 weeks Body measurements will be taken at Weeks 24 48 72 and 96 Whole body dual-energy x-ray absorptiometry DEXA scans will be done at Weeks 48 and 96 Patients must fast before study visits at Weeks 12 24 48 72 and 96 Women in the study will have gynecological assessments every 24 weeks
Patients will be randomly assigned to one of three study arms In Arm A patients will receive lopinavirritonavir LPVr twice daily and efavirenz EFV once daily before bed Arm B patients will receive LPVr twice daily lamivudine 3TC once daily plus either stavudine extended release d4T XR once daily zidovudine ZDV twice daily or tenofovir disoproxil fumarate TDF once daily Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed ZDV twice daily or TDF once daily before bed
Study visits will occur every 4 weeks until Week 24 then every 8 weeks thereafter for a maximum of 96 weeks Blood will be drawn at every visit and a urine sample will be collected every 8 weeks Body measurements will be taken at Weeks 24 48 72 and 96 Whole body dual-energy x-ray absorptiometry DEXA scans will be done at Weeks 48 and 96 Patients must fast before study visits at Weeks 12 24 48 72 and 96 Women in the study will have gynecological assessments every 24 weeks
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 |
|---|---|---|---|
| A5160s | Registry Identifier | DAIDS ES | None |
| 10085 | REGISTRY | None | None |
| ACTG A5142 | None | None | None |
| A5152s | None | None | None |