A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients - Full Text View

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

U.S. FDA Resources

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

80

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002383

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

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Publications:

Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. No abstract available.

Study ID Numbers:	229M, NV15107
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002383
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Administration Schedule
HIV Protease Inhibitors
Dosage Forms
Saquinavir
Anti-HIV Agents

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Saquinavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009