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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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. 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 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically receive the most expert healthcare available for their 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 condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - 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 Co-existing Condition: 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.
Total Enrollment: 140
Location and Contact Information:
Infectious Diseases Association of Houston
Houston, Texas, 77030
United States
UCLA AIDS Clinical Research Ctr / Dept of Medicine
Los Angeles, California, 90024
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
UCD Med Ctr
Sacramento, California, 95817
United States
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121
United States
UCSD Treatment Ctr
San Diego, California, 921036329
United States
AIDS Research Ctr
Palo Alto, California, 94304
United States
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta,
Canada
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, 70122
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Oklahoma
Oklahoma City, Oklahoma, 73117
United States
Mount Zion Hosp of UCSF
San Francisco, California, 94115
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Saint Paul's Hosp / Canadian HIV Trials Network
Vancouver, British Columbia,
Canada
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
Univ of Pennsylvania / Division of Infectious Disease
Philadelphia, Pennsylvania, 19104
United States
McMaster Univ Med Ctr
Hamilton, Ontario,
Canada
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Phoenix Body Positive
Phoenix, Arizona, 85016
United States
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec,
Canada
St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
New York City, New York, 10011
United States
Saint Joseph's Hosp
Tampa, Florida, 33614
United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: 229D; NV15355
Study Start Date:
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002162
Other Hiv Infections Studies:
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2. Effects of Therapeutic HIV Vaccination on Control of HIV after Discontinuation of Anti-HIV Drugs
3. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B
4. An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium avium-intracellulare Complex Infection (MAC) in Patients with Acquired Immune Deficiency Syndrome (AIDS)
5. The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
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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
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