A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients
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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 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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:
- 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| United States, California | |
| UCLA Care Ctr | |
| Los Angeles, California, United States, 900951793 | |
| Palo Alto Veterans Affairs Health Care System | |
| Palo Alto, California, United States, 94304 | |
| 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002448 History of Changes |
| Other Study ID Numbers: | 229S, M61028 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| 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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Protease Inhibitors Saquinavir |
Ritonavir Reverse Transcriptase Inhibitors Efavirenz Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013