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A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 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 A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients Clinical research trials and A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 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 A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients. A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 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 A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients clinical trial. Participants frequently obtain the most expert healthcare available for their A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 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 > "A" Clinical Trials Conditions > A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients  A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients
A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.
Details: Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - CD4 > 100 cells/mm3. - Saquinavir HGC-experienced patients (>= 3 months cumulative therapy). Required: >= 3 months cumulative saquinavir HGC therapy.
Total Enrollment: 120
Location and Contact Information:
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048
United States
AIDS Ctr
New York City, New York, 10011
United States
Pacific Oaks Med Ctr
Beverly Hills, California, 90211
United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445
United States
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, 15213
United States
Ctr for Quality Care
Tampa, Florida, 33609
United States
Additional Information:
Study ID Numbers: 229G; NR15521
Study Start Date:
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002374
Other Hiv Infections Studies:
1. Strategies for Delivering Anti-HIV Therapy in South Africa
2. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
3. A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection
4. 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.
5. Pulmonary Complications of HIV Infection Study (PACS)
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A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients
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