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| Sponsor: | 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 |
| 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 1999 |
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 |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and 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 | |
| Principal Investigator: | Mark Holodniy | |
| Study Chair: | Joseph John | |
| Study Chair: | Ronald Mitsuyasu |
More Information
| Study ID Numbers: | 229S, M61028 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002448 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination HIV Protease Inhibitors Ritonavir Dosage Forms |
Saquinavir Reverse Transcriptase Inhibitors Anti-HIV Agents efavirenz |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |
