Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002448
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Evaluation of Immune Reconstitution in HIV Infected Patients Treated With Fortovase Saquinavir SGC QD Plus Ritonavir QD Plus 2 NRTIs Vs Efavirenz QD Plus 2 NRTIs
Status:
COMPLETED
Status Verified Date:
2001-01
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 examine how the immune systems of HIV-infected patients react to 2 anti-HIV drug combinations
Detailed Description:
Patients are randomized to two study arms for at least 48 weeks of treatment Arm A receives SQV SGC plus RTV plus two NRTIs of choice Arm B receives EFV plus two NRTIs of choice NRTIs approved for study use are stavudine d4T didanosine ddI zidovudine AZT lamivudine 3TC Combivir and zalcitabine ddC Abacavir is excluded The following immunology variables and HIV-1 viral characteristics will be evaluated during study visits CD4 and CD8 cell counts naive and memory T-cells T-cell activation markers HLA-DR and CD38 T-cells expressing T helper 1- TH1- and T helper 2- TH2- associated intracytoplasmic cytokines anti-CD3 T-cell activation responses T-cell receptor V Beta repertoire cytotoxic T-lymphocyte CTL activity levels lymph node histology optional HIV-1 qualitative microcultures and viral phenotyping for non-syncytium-inducing NSI and syncytium-inducing SI viral isolates Laboratory determinations adverse effects neurological exams including mental status evaluations and lipodystrophy parameters including fasting lipid profile and physical parameters also are evaluated
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 |
|---|---|---|---|
| M61028 | None | None | None |