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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002383 |
Purpose
To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Saquinavir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Pharmacokinetics Study |
| Official Title: | A Randomized, Parallel, Open-Label Study Comparing Saquinavir (Hard Gelatin Formulation, 600 Mg Tid) to Saquinavir Soft Gelatin Formulation [(400 Mg, 800 Mg, 1200 Mg) Tid} x 4 Weeks in HIV Infected Patients |
| Estimated Enrollment: | 80 |
Patients are randomly assigned to one of the four treatment groups as follows:
Group 1: 10 patients receive saquinavir HGC. Group 2: 10 patients receive saquinavir SGC. Group 3: 30 patients receive saquinavir SGC at an intermediate dose. Group 4: 30 patients receive saquinavir SGC at the highest study dose. Upon completion of the initial 4 weeks, all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes. If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC, patients may have the option to change to this optimal dose in a treatment extension phase of the protocol. Patients in this extension phase may choose to remain on monotherapy unless they experience significant drug toxicity, their CD4 count or HIV-RNA levels return to baseline, until saquinavir is approved by the FDA or study termination, whichever comes first. NOTE: A washout >= 28 days is required for patients on antiretroviral therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Prior Medication:
Excluded:
Prior treatment with protease inhibitors.
Required:
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham / 1917 Rsch Cln | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Pacific Oaks Med Group / Research & Scientific Investiga | |
| Sherman Oaks, California, United States, 91403 | |
| Davis Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Mt Zion Hosp of UCSF / HIV Research Ctr | |
| San Francisco, California, United States, 94115 | |
| United States, Louisiana | |
| Tulane Univ Med Ctr / Infectious Diseases Sect | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Missouri | |
| Kansas City AIDS Research Consortium | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New York | |
| Harkness Pavilion | |
| New York, New York, United States, 10032 | |
| United States, Oregon | |
| Oregon Health Sciences Univ | |
| Portland, Oregon, United States, 97201 | |
| United States, Texas | |
| Univ of Texas Med Branch / Virology Clinic | |
| Galveston, Texas, United States, 775550882 | |
More Information
| Study ID Numbers: | 229M, NV15107 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002383 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Administration Schedule HIV Protease Inhibitors Dosage Forms Saquinavir Anti-HIV Agents |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Saquinavir Acquired Immunodeficiency Syndrome Antiviral Agents |
Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Saquinavir Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
