A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1997
History of Changes
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.
Drug : Saquinavir
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- CD4 count of 100 to 500 cells/mm3.
- Greater than 20,000 HIV-RNA copies/ml.
- 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).
Prior treatment with protease inhibitors.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002383
Locations Show More
|United States, Alabama|
|Univ of Alabama at Birmingham / 1917 Rsch Cln|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Davis Med Ctr|
|San Francisco, California, United States, 94114|
|Mt Zion Hosp of UCSF / HIV Research Ctr|
|San Francisco, California, United States, 94115|
|Pacific Oaks Med Group / Research & Scientific Investiga|
|Sherman Oaks, California, United States, 91403|
|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|
|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|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002383 History of Changes|
|Other Study ID Numbers:||229M|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Drug Administration Schedule
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.