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A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

Phase 2
Completed
Conditions
HIV Infections
Registration Number
NCT00002162
Lead Sponsor
Hoffmann-La Roche
Brief Summary

To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.

Detailed Description

Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (27)

Phoenix Body Positive

🇺🇸

Phoenix, Arizona, United States

UCLA AIDS Clinical Research Ctr / Dept of Medicine

🇺🇸

Los Angeles, California, United States

AIDS Research Ctr

🇺🇸

Palo Alto, California, United States

UCD Med Ctr

🇺🇸

Sacramento, California, United States

UCSD Treatment Ctr

🇺🇸

San Diego, California, United States

Mount Zion Hosp of UCSF

🇺🇸

San Francisco, California, United States

San Francisco Veterans Adm Med Cntr

🇺🇸

San Francisco, California, United States

Univ of Colorado Health Sciences Ctr

🇺🇸

Denver, Colorado, United States

Whitman Walker Clinic

🇺🇸

Washington, District of Columbia, United States

Miami Veterans Administration Med Ctr

🇺🇸

Miami, Florida, United States

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Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
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