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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 |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Saquinavir Saquinavir mesylate Gelatin |
| 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 | |||||
| Hoffmann-La Roche |
More Information
| Study ID Numbers: | 229M, NV15107 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002383 |
| Health Authority: | United States: Food and Drug Administration |
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