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A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients Clinical research trials and A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients. A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients clinical trial. Subjects typically recieve the finest healthcare available for their A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients  A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.
Details: Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV RNA >= 5000 copies/ml by Amplicor assay. - Signed, informed consent from parent or legal guardian for patients less than 18 years old. Previous treatment with antiretrovirals.
Total Enrollment: 375
Location and Contact Information:
Community Research Initiative
Brookline, Massachusetts, 02445
United States
Dr Charles Farthing
Los Angeles, California, 90048
United States
Additional Information:
Study ID Numbers: 229J; NR15539
Study Start Date:
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002178
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease
2. A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy
3. A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
4. Alternative Dosing Strategy for Anti-HIV Drugs
5. A Study of Tecogalan Sodium
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A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
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