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Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients Clinical research trials and Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients. Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients clinical trial. Participants frequently obtain the most expert healthcare available for their Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
Details: Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 16 Years/64 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have an HIV count of 5,000 copies/ml or more. - Have a CD4 count of 100 cells/mm3 or more. - Meet specific requirements if you have ever taken NRTIs. - Are 16 - 64 years old (need consent if under 18). - Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: - Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks. - Have taken all the available NRTIs. - Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection. - Have a history of weight loss, muscle pain, and loss of appetite. - Have taken certain medications, including anti-HIV drugs other than those required by this study. - Are pregnant or breast-feeding. - Abuse alcohol or drugs. - Are unable to complete the study for any reason.
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
SPalleja, Study Chair,
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
United States
Dean Martin
Phoenix, Arizona, 85006
United States
Programe DeSIDA De San Juan
San Turce, , 00908
Puerto Rico
Brookdale Univ Med Ctr
Brooklyn, New York, 11212
United States
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, 07103
United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908
United States
SUNY Health Sciences Ctr
Brooklyn, New York, 11203
United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Duval County Health Department
Jacksonville, Florida, 32206
United States
Wilbert Jordan
Paramount, California, 90723
United States
Harlem Hosp Infectious Disease
New York City, New York, 10037
United States
Univ of Illinois Hosp at Chicago
Chicago, Illinois, 60612
United States
Univ of British Columbia Oak Tree Clinic
Vancouver, British Columbia,
Canada
Univ of Kentucky
Lexington, Kentucky, 40536
United States
NTouch Research Corp
Decatur, Georgia, 30033
United States
Diversified Med Practices, PA
Houston, Texas, 77027
United States
C100 HIV Outpatient Program
New Orleans, Louisiana, 70112
United States
Mt Vernon Hosp
Mt. Vernon, New York, 10550
United States
ASC Inc
Hobson City, Alabama, 36201
United States
Mount Sinai Med Ctr
New York City, New York, 100296574
United States
NJ CRI
Newark, New Jersey, 07103
United States
Ctr for Quality Care
Tampa, Florida, 33609
United States
Additional Information:
Study ID Numbers: 229Q; NR15750
Study Start Date:
Record last reviewed: December 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002229
Other Hiv Infections Studies:
1. A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
2. Follow-up Protocol for Patients with Cancer/AIDS/Skin Disease
3. A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients with Acquired Immunodeficiency Related Diarrhea who were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
4. 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
5. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Related Studies:
Other HIV Infections Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
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