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| Sponsored by: |
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 |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| ChemIDplus related topics: | Stavudine Nelfinavir Nelfinavir Mesylate Ritonavir Saquinavir Saquinavir mesylate Gelatin |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| 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 | |||||
| Tower Infectious Diseases / Med Associates Inc | |||||
| Los Angeles, California, United States, 90048 | |||||
| Pacific Oaks Med Ctr | |||||
| Beverly Hills, California, United States, 90211 | |||||
| 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 | |||||
| Hoffmann-La Roche |
More Information
| Study ID Numbers: | 229G, NR15521 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002374 |
| Health Authority: | United States: Food and Drug Administration |
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