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Home > "A" Clinical Trials Conditions > A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients  A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 80
Location and Contact Information:
New England Med Ctr
Boston, Massachusetts, 02111
United States
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, 35294
United States
Pacific Oaks Med Group / Research & Scientific Investiga
Sherman Oaks, California, 91403
United States
Tulane Univ Med Ctr / Infectious Diseases Sect
New Orleans, Louisiana, 70112
United States
Davis Med Ctr
San Francisco, California, 94114
United States
Oregon Health Sciences Univ
Portland, Oregon, 97201
United States
Harkness Pavilion
New York City, New York, 10032
United States
Mt Zion Hosp of UCSF / HIV Research Ctr
San Francisco, California, 94115
United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64108
United States
Univ of Texas Med Branch / Virology Clinic
Galveston, Texas, 775550882
United States
Additional Information:
Study ID Numbers: 229M; NV15107
Study Start Date:
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002383
Other Hiv Infections Studies:
1. KSHV Infection in Blood Donors from Texas
2. A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells
3. Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
4. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
5. A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
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