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A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical research trials and A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs. A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs clinical trial. Human subjects often obtain the finest healthcare possible for their A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs  A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.
Details: In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Local treatment for Kaposi's sarcoma. - GM-CSF, G-CSF or erythropoietin. Patients must have: - HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture. - CD4+ cell count >= 100 cells/mm3 within 14 days of study drug administration. - HIV-1 RNA >= 5,000 copies/ml within 14 days of study drug administration. - No active or ongoing AIDS-defining opportunistic infection or disease. - Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Prior Medication: Allowed: Local treatment for Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication. - Life-threatening infection or other serious medical condition that may compromise a patient's safety. Concurrent Medication: Excluded: - Other investigational agents. NOTE: - Those available through Treatment IND or expanded access programs are evaluated individually. - Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma). - Agents with documented anti-HIV activity in vitro. - Foscarnet. - Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons. - Antioxidants. Concurrent Treatment: Excluded: Radiation therapy within the first 24 weeks of study. Patients with the following prior conditions are excluded: - History of clinically relevant pancreatitis or hepatitis within the last 6 months. - Participation in an investigational HIV-1 vaccine trial. Prior Medication: Excluded: - Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy. - Cytotoxic chemotherapeutic agents within 30 days of study drug administration. - HIV-1 vaccine dose within the 3 months prior to study drug administration. - Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration. Prior Treatment: Excluded: Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.
Total Enrollment: 80
Location and Contact Information:
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213
United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, 065102483
United States
NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial
New York City, New York, 10016
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372321302
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28232
United States
UCSD Treatment Ctr
San Diego, California, 921036329
United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111
United States
Case Western Reserve Univ / AIDS Clinical Trials Unit
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: 238J; CNAA2004
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002440
Other Hiv Infections Studies:
1. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
2. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
3. A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients with Cytopenia
4. A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
5. A Study of BufferGel in Women
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A Study of 1592U89 in Combination with Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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