Back to resultsA Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Saquinavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Administration Schedule, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria Patients must have: CD4 count of 100 to 500 cells/mm3. Greater than 20,000 HIV-RNA copies/ml. Exclusion Criteria Prior Medication: 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).
Sites / Locations
- Univ of Alabama at Birmingham / 1917 Rsch Cln
- Davis Med Ctr
- Mt Zion Hosp of UCSF / HIV Research Ctr
- Pacific Oaks Med Group / Research & Scientific Investiga
- Tulane Univ Med Ctr / Infectious Diseases Sect
- New England Med Ctr
- Kansas City AIDS Research Consortium
- Harkness Pavilion
- Oregon Health Sciences Univ
- Univ of Texas Med Branch / Virology Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002383
Brief Title
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Administration Schedule, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Saquinavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
CD4 count of 100 to 500 cells/mm3.
Greater than 20,000 HIV-RNA copies/ml.
Exclusion Criteria
Prior Medication:
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).
Facility Information:
Facility Name
Univ of Alabama at Birmingham / 1917 Rsch Cln
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Davis Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Mt Zion Hosp of UCSF / HIV Research Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pacific Oaks Med Group / Research & Scientific Investiga
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Tulane Univ Med Ctr / Infectious Diseases Sect
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Harkness Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Univ of Texas Med Branch / Virology Clinic
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550882
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11364377
Citation
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
Results Reference
background
Learn more about this trial
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
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