|
The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs Clinical research trials and The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs. The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs clinical trial. Human subjects often get the best healthcare available for their The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs  The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
Details: Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - CD4+ cell count <= 200 cells/mm3. - Life expectancy > 3 months. - Written informed consent from parent or guardian for patients < 18 years of age. - Willingness and ability to follow protocol requirements. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: Patient is enrolled or plans to enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection. - NOTE: - Patients are allowed to participate in opportunistic infection clinical studies if the investigational agent is not contraindicated for the study. Concurrent Medication: Excluded: - Patient is receiving therapy with an antiretroviral agent other than ZDV, d4T, ddI, ddC, or 3TC. - Patient is receiving acute therapy for a clinical AIDS progression event such as systemic chemotherapy. - Dicumarol, Warfarin and other anticoagulant medications. - Tolbutamide. - Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC). - Neurotoxic drugs. - Cimetidine. - Erythromycin. Concurrent Treatment: Excluded: Radiation therapy. Patients with any of the following prior conditions and symptoms are excluded: History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study. Prior Medication: Excluded: - Patient has received prior therapy with Viramune or any other non-nucleoside reverse transcriptase inhibitor. - Patient has received any immunosuppressive or cytotoxic drugs or any other experimental agent within 4 weeks prior to study day 1. - Patient has received treatment with erythromycin, coumadin/warfarin, phenobarbital, amoxicillin/clavulanic acid, or ticarcillin/clavulanic acid within 2 weeks prior to study day 0. Risk Behavior: Excluded: Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements. Required: Patient must be receiving stable nucleoside therapy with at least one agent for >= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose > 50% for any background nucleoside within four weeks prior to study day 0. NOTE: - If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed.
Total Enrollment: 2000
Location and Contact Information:
AIDS Community Research Consortium
Redwood City, California, 94063
United States
Drug Research and Analysis Corp
Montgomery, Alabama, 36104
United States
Dr G Michael Wool
Los Angeles, California, 90067
United States
Anthony LaMarca
Ft. Lauderdale, Florida, 33308
United States
McGregor Clinic / Lee County Public Health Unit
Ft. Myers, Florida, 33901
United States
Infectious Disease Associates of Central New Jersey
Somerville, New Jersey, 08876
United States
Dr Susie Sargent
Memphis, Tennessee, 38163
United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
Palm Beach Research Ctr
West Palm Beach, Florida, 33409
United States
International Medicine and Infectious Disease
Minneapolis, Minnesota, 55407
United States
Med Research Ctr
New Orleans, Louisiana, 70112
United States
AIDS Research Ctr / Palo Alto VA Health Care System
Palo Alto, California, 94304
United States
New England Deaconess Hosp
Boston, Massachusetts, 02215
United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
United States
Univ of Iowa
Iowa City, Iowa, 52242
United States
Dr Robert Schwartz
Ft. Myers, Florida, 33901
United States
Novum Inc
Pittsburgh, Pennsylvania, 152063817
United States
Harbor - UCLA Med Ctr
Torrance, California, 90502
United States
Denver Public Health
Denver, Colorado, 80204
United States
ViRx Inc
San Francisco, California, 94109
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33316
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Dr Daniel H Gervich
Des Moines, Iowa, 50325
United States
Dr David Kaufman
New York City, New York, 10014
United States
Dr Alfred Burnside
Columbia, South Carolina, 29206
United States
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, 900951793
United States
Walter Gaman
Irving, Texas, 75038
United States
Novum Inc
Washington D.C., District of Columbia, 20037
United States
Indiana Univ Med School
Indianapolis, Indiana, 46202
United States
Med Univ of South Carolina / Div of Infect Dis
Charleston, South Carolina, 29425
United States
Dr Miguel Mogyoros / Clinical Research Dept
Denver, Colorado, 80205
United States
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
United States
Hershey Med Ctr / Dept of Med / Div of Hematology
Hershey, Pennsylvania, 17033
United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Dr John Pottage
Chicago, Illinois, 60610
United States
Advanced Research Management
Seattle, Washington, 981225314
United States
Saint Vincent Med Ctr
Staten Island, New York, 10310
United States
Univ of Kentucky Med Cntr / Dept of Med / Div of ID
Lexington, Kentucky, 40563
United States
Wilmington Hosp
Wilmington, Delaware, 19801
United States
Nelson Tebedo Health Resource Ctr
Dallas, Texas, 75219
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, 60612
United States
P Andrew Coley
Jacksonville, Florida, 32216
United States
Univ of Pennsylvania / Division of Infectious Diseases
Philadelphia, Pennsylvania, 19104
United States
Univ of Texas Med Branch / Div of Infectious Dis
Galveston, Texas, 775550835
United States
Trinity Lutheran Hosp / HIV Program
Kansas City, Missouri, 64108
United States
Northwestern Univ / Division of Infectious Diseases
Chicago, Illinois, 60611
United States
Infectious Disease Specialists
Colorado Springs, Colorado, 80903
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Beth Israel Hosp / Virology Research Clinic
Boston, Massachusetts, 02215
United States
Omega Med Research
Providence, Rhode Island, 02907
United States
Goodgame Med Group
Maitland, Florida, 32751
United States
Additional Information:
Study ID Numbers: 200E; 1100.1090
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002368
Other Hiv Infections Studies:
1. A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS
2. Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
3. L-Carnitine to Treat Fatigue in AIDS Patients
4. Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
5. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
|
|
|
|
|
|
|
|
