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
NCT ID: NCT00002162
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
140 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saquinavir
Lamivudine
Stavudine
Zidovudine
Zalcitabine
Didanosine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HIV infection.
* Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs.
* No more than 2 weeks of prior treatment with a protease inhibitor.
* No active opportunistic infection or other serious AIDS-defining condition.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Malabsorption or inadequate oral intake.
* Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations).
* Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry.
* Active malignancy or anticipated need for chemotherapy during the study.
* Anticipated need for disallowed medications during the study.
Concurrent Medication:
Excluded:
* Other protease inhibitors.
Prior Medication:
Excluded:
* More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen.
* More than 2 weeks of any protease inhibitor.
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 D.C., District of Columbia, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Saint Joseph's Hosp
Tampa, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, United States
New England Med Ctr
Boston, Massachusetts, United States
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, United States
Beth Israel Med Ctr
New York, New York, United States
St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
New York, New York, United States
Univ of Oklahoma
Oklahoma City, Oklahoma, United States
Univ of Pennsylvania / Division of Infectious Disease
Philadelphia, Pennsylvania, United States
Univ of Texas Med Branch
Galveston, Texas, United States
Infectious Diseases Association of Houston
Houston, Texas, United States
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta, Canada
Saint Paul's Hosp / Canadian HIV Trials Network
Vancouver, British Columbia, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
Mitsuyasu RT, Skolnik PR, Cohen SR, Conway B, Gill MJ, Jensen PC, Pulvirenti JJ, Slater LN, Schooley RT, Thompson MA, Torres RA, Tsoukas CM. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team. AIDS. 1998 Jul 30;12(11):F103-9. doi: 10.1097/00002030-199811000-00001.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NV15355
Identifier Type: -
Identifier Source: secondary_id
229D
Identifier Type: -
Identifier Source: org_study_id