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| Descriptive Information Fields | |||||||||||||
| 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 | ||||||||||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Treatment, Parallel Assignment | ||||||||||||
| Primary Outcome Measure † | |||||||||||||
| Secondary Outcome Measure † | |||||||||||||
| Condition † | HIV Infections | ||||||||||||
| Intervention † | Drug: Ritonavir Drug: Efavirenz Drug: Saquinavir |
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| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Completed | ||||||||||||
| Enrollment † | 40 | ||||||||||||
| Start Date † | October 1999 | ||||||||||||
| Completion Date | |||||||||||||
| Eligibility Criteria † | Inclusion Criteria Patients may be eligible for this study if they:
Exclusion Criteria Patients will not be eligible for this study if they:
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| Gender | Both | ||||||||||||
| Ages | 16 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts †† | |||||||||||||
| Location Countries † | United States | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00002448 | ||||||||||||
| Organization ID | 229S | ||||||||||||
| Secondary IDs †† | M61028 | ||||||||||||
| Study Sponsor † | Hoffmann-La Roche | ||||||||||||
| Collaborators †† | |||||||||||||
| Investigators † |
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| Information Provided By | NIH AIDS Clinical Trials Information Service | ||||||||||||
| Verification Date | January 2001 | ||||||||||||
| First Received Date † | November 2, 1999 | ||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||