A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
NCT ID: NCT00002383
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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Saquinavir
Eligibility Criteria
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Inclusion Criteria
* CD4 count of 100 to 500 cells/mm3.
* Greater than 20,000 HIV-RNA copies/ml.
Exclusion Criteria
Excluded:
Prior treatment with protease inhibitors.
Required:
* Less than 8 weeks prior antiretroviral treatment (For at least 25% of patients).
* At least 8 weeks prior antiretroviral treatment (For at least 25% of patients).
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Locations
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Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, United States
Davis Med Ctr
San Francisco, California, United States
Mt Zion Hosp of UCSF / HIV Research Ctr
San Francisco, California, United States
Pacific Oaks Med Group / Research & Scientific Investiga
Sherman Oaks, California, United States
Tulane Univ Med Ctr / Infectious Diseases Sect
New Orleans, Louisiana, United States
New England Med Ctr
Boston, Massachusetts, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States
Harkness Pavilion
New York, New York, United States
Oregon Health Sciences Univ
Portland, Oregon, United States
Univ of Texas Med Branch / Virology Clinic
Galveston, Texas, United States
Countries
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References
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Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
Other Identifiers
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NV15107
Identifier Type: -
Identifier Source: secondary_id
229M
Identifier Type: -
Identifier Source: org_study_id