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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002374 |
Purpose
To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Stavudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection |
| Estimated Enrollment: | 120 |
Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Required:
>= 3 months cumulative saquinavir HGC therapy.
Contacts and Locations| United States, California | |
| Pacific Oaks Med Ctr | |
| Beverly Hills, California, United States, 90211 | |
| Tower Infectious Diseases / Med Associates Inc | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Community Research Initiative of South Florida | |
| Coral Gables, Florida, United States, 33146 | |
| Ctr for Quality Care | |
| Tampa, Florida, United States, 33609 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, New York | |
| AIDS Ctr | |
| New York, New York, United States, 10011 | |
| United States, Pennsylvania | |
| Anderson Clinical Research / Inc | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002374 History of Changes |
| Other Study ID Numbers: | 229G, NR15521 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Therapy, Combination Acquired Immunodeficiency Syndrome HIV Protease Inhibitors |
RNA, Viral Saquinavir Anti-HIV Agents Viral Load |
|
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 |
Nelfinavir Stavudine Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antimetabolites Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
