Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000922
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy HAART
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy HAART Strategies in HAART-Niave HIV-Infected Persons
Status:
COMPLETED
Status Verified Date:
2014-04
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 whether it is better to start an anti-HIV regimen containing a protease inhibitor PI a non-nucleoside reverse transcriptase inhibitor NNRTI or a PI in combination with an NNRTI This study will also examine which treatment regimen is best as a first treatment for HIV infection
Detailed Description:
Highly active antiretroviral therapy HAART regimens containing PIs NNRTIs or nucleoside reverse transcriptase inhibitors NRTIs have been shown to slow disease progression However the long-term consequences of initial therapy with a PI an NNRTI or both a PI and an NNRTI are not yet known nor is the impact on future anti-HIV treatment regimens Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent anti-HIV treatment regimens
Patients will be randomized to one of three HAART treatment arms
Arm 1 participants will receive one or two PIs plus two NRTIs
Arm 2 participants will receive one NNRTI plus two NRTIs
Arm 3 participants will receive one or two PIs plus an NNRTI plus one or two NRTIs
Before randomization to a treatment arm patients will be given the option of preselecting the drugs they will use or allowing randomization to study-specified drugs The study-specified PIs will be indinavir IDV nelfinavir NFV or two PIs of patient and doctor choice The study-specified NNRTIs will be nevirapine NVP or efavirenz EFV The study-specified NRTIs will be abacavir ABC plus lamivudine 3TC or didanosine ddI plus stavudine d4T
The study sites will provide ABC 3TC ddI or d4T to all patients who are assigned to take these medications All other anti-HIV drugs for initial and subsequent treatment regimens are obtained by clinician prescription At Months 1 and 4 and then every 4 months thereafter patients will receive a medical history update physical exam and questionnaire Blood samples will also be drawn to measure CD4 cell count viral load and genotypic antiretroviral resistance Changes in treatment regimens may occur at any time
Patients will be randomized to one of three HAART treatment arms
Arm 1 participants will receive one or two PIs plus two NRTIs
Arm 2 participants will receive one NNRTI plus two NRTIs
Arm 3 participants will receive one or two PIs plus an NNRTI plus one or two NRTIs
Before randomization to a treatment arm patients will be given the option of preselecting the drugs they will use or allowing randomization to study-specified drugs The study-specified PIs will be indinavir IDV nelfinavir NFV or two PIs of patient and doctor choice The study-specified NNRTIs will be nevirapine NVP or efavirenz EFV The study-specified NRTIs will be abacavir ABC plus lamivudine 3TC or didanosine ddI plus stavudine d4T
The study sites will provide ABC 3TC ddI or d4T to all patients who are assigned to take these medications All other anti-HIV drugs for initial and subsequent treatment regimens are obtained by clinician prescription At Months 1 and 4 and then every 4 months thereafter patients will receive a medical history update physical exam and questionnaire Blood samples will also be drawn to measure CD4 cell count viral load and genotypic antiretroviral resistance Changes in treatment regimens may occur at any time
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 |
|---|---|---|---|
| 11611 | REGISTRY | DAIDS-ES | None |