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A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002448
  Purpose

The purpose of this study is to examine how the immune systems of HIV-infected patients react to 2 anti-HIV drug combinations.


Condition Intervention Phase
HIV Infections
Drug: Ritonavir
Drug: Efavirenz
Drug: Saquinavir
Phase III

MedlinePlus related topics:   AIDS    AIDS Medicines   

Drug Information available for:   Efavirenz    Ritonavir    Saquinavir    Saquinavir mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Parallel Assignment
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   40
Study Start Date:   October 1999

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002448

Locations
United States, California
Palo Alto Veterans Affairs Health Care System    
      Palo Alto, California, United States, 94304
UCLA Care Ctr    
      Los Angeles, California, United States, 900951793
United States, New Jersey
Robert Wood Johnson Med School/UMDNJ    
      New Brunswick, New Jersey, United States, 089030019

Sponsors and Collaborators
Hoffmann-La Roche

Investigators
Principal Investigator:     Mark Holodniy    
Study Chair:     Joseph John    
Study Chair:     Ronald Mitsuyasu    
  More Information


Study ID Numbers:   229S, M61028
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002448
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
HIV Protease Inhibitors  
Ritonavir  
Dosage Forms  
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
efavirenz

Study placed in the following topic categories:
Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Saquinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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