Back to resultsA Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Efavirenz
Saquinavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load of at least 5,000 copies/ml and a CD4 cell count greater than 75 cells/mm3. Are at least 16 (need consent of parent or guardian if under 18). Are able to complete the study. Exclusion Criteria Patients will not be eligible for this study if they: Have ever taken anti-HIV medications. Are pregnant or breast-feeding.
Sites / Locations
- UCLA Care Ctr
- Palo Alto Veterans Affairs Health Care System
- Robert Wood Johnson Med School/UMDNJ
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002448
Brief Title
A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Saquinavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
Are HIV-positive.
Have a viral load of at least 5,000 copies/ml and a CD4 cell count greater than 75 cells/mm3.
Are at least 16 (need consent of parent or guardian if under 18).
Are able to complete the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
Have ever taken anti-HIV medications.
Are pregnant or breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Holodniy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph John
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ronald Mitsuyasu
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA Care Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951793
Country
United States
Facility Name
Palo Alto Veterans Affairs Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Robert Wood Johnson Med School/UMDNJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients
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