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Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients Clinical research trials and Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients. Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients clinical trial. Test subjects typically receive the most effective healthcare possible for their Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients  Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications. It is thought that IDV plus NFV will be a safe drug combination for treating HIV.
Details: It is hypothesized that the administration of indinavir with nelfinavir will be generally safe and well tolerated. This is a parallel, time-lagged, 2-stage, multiple-dose, 24-week study in HIV-1 seropositive patients. In the 3-week, randomized, double-blind phase of Stage A, patients receive either indinavir plus nelfinavir (Group A1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group A2: 3 patients) for the first week. In Week 2, patients in Group A1 have the nelfinavir dose increased. This dose escalation for nelfinavir is contingent upon the patient having completed 1 week of the study drugs without experiencing Grade 3 or worse toxicity and/or serious drug-related adverse events. Patients in Group A2 continue to receive placebo until Week 3, at which time they receive indinavir plus nelfinavir (initial dose), while patients in Group A1 continue with indinavir plus nelfinavir (escalated dose). At Week 4 all patients in Stage A (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir (escalated dose) for the remainder of the 24 weeks. After at least 6 patients in Stage A have completed at least 2 weeks of therapy with nelfinavir plus indinavir with acceptable tolerability, Stage B begins. In the 2-week, randomized, double-blind phase of Stage B, patients receive either indinavir plus nelfinavir (Group B1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group B2, 3 patients). After 2 weeks, all patients in Stage B (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have a CD4 count of at least 100 cells/mm3. - Have a plasma viral load (level of HIV in the blood) of at least 30,000 copies/ml. - Are at least 18 years old. Exclusion Criteria You will not be eligible for this study if you: - Have ever been treated with any protease inhibitors (PIs).
Total Enrollment: 24
Location and Contact Information:
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, 15261
United States
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, 92103
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: 246H; MK-0639,061-00
Study Start Date:
Record last reviewed: February 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002375
Other Hiv Infections Studies:
1. The Effects of r-metHuIFN-gamma on the Lungs of Patients with AIDS
2. Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
3. A Study of Peldesine (BCX-34) in HIV-Infected Patients
4. A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma
5. Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
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