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Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir Clinical research trials and Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir. Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir clinical trial. Human subjects often receive the most effective healthcare possible for their Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir  Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.
Details: In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Serologically documented HIV infection. - Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml. - Parental consent for patients under 18. Nelfinavir-Failure Group: - Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent. - Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold). Control Group: - Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks. - Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's. Exclusion Criteria Prior Medication: Excluded: Control group: - Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors. Required: Nelfinavir-failure patients: - At least 16 weeks of nelfinavir. Control group: - At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
Total Enrollment: 120
Location and Contact Information:
AIDS TMT Unit / Univ Hosp
Stony Brook, New York, 117948153
United States
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033
United States
Rush Presbyterian Saint Lukes Med Ctr
Chicago, Illinois, 606123832
United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, 96816
United States
Vanderbilt Clinic
Nashville, Tennessee, 37212
United States
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, 06510
United States
Oaklawn Physicians Group
Dallas, Texas, 75219
United States
Columbia Presbyterian Hosp
New York City, New York, 10032
United States
Med Ctr of Delaware
Wilmington, Delaware, 19899
United States
Johns Hopkins Hosp
Baltimore, Maryland, 212876220
United States
Additional Information:
Study ID Numbers: 246N; 075-00
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002220
Other Hiv Infections Studies:
1. A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in Patients With AIDS Post First Episode PCP
2. A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients with HIV-Associated Immune Thrombocytopenic Purpura
3. The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
4. Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN alfa-2b), and Ribavirin (RBV) Treatment in Patients with Hepatitis C and HIV Coinfection
5. Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
Related Studies:
Other HIV Infections Clinical Trials
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Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir
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