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Home > "C" Clinical Trials Conditions > Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients with No Symptoms of the Disease  Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients with No Symptoms of the Disease
Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients with No Symptoms of the Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: To validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine (AZT). To determine whether alternative regimens of antiretroviral agents alter the course of viral burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To obtain further data on the safety and immunologic and virologic response to AZT/didanosine/nevirapine. Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.
Details: Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration. Initially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 years. AS PER AMENDMENT 5/9/96: All AZT monotherapy options have been eliminated. Patients will be randomized to either Arm II or Arm III, regardless of their codon 215 status. All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III. All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Chemoprophylaxis for Pneumocystis carinii pneumonia. - Antibiotics, antifungals, and antiviral medications, as clinically indicated. - Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider. Concurrent Treatment: Allowed: - Limited localized radiation therapy to the skin. Prior Medication: Required: - AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry. Patients must have: - Asymptomatic HIV infection. - CD4 count 300-600 cells/mm3. - No plasma/serum PCR for codon 215 mutation at screening. - Prior AZT monotherapy. NOTE: - All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged. AS PER AMENDMENT 04/03/95: - DOD female patients must have a negative pregnancy test within 48 hours prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Symptomatic grade 2 or worse peripheral neuropathy. - Unable to swallow capsules and tablets. - Other medical condition that contraindicates study participation. Concurrent Medication: Excluded: - Systemic cytotoxic chemotherapy. - Biologic response modifiers (such as interferon, ampligen, or PEG-IL2). - Anti-HIV agents other than study drugs. - Other investigational agents. - Foscarnet unless clinically indicated for unresponsive herpes virus infection. - Chronic antacid or H-2 blocker use. - Rifampin or rifamycin class agents. - Antibiotics containing clavulanic acid. Concurrent Treatment: Excluded: - Radiation therapy other than limited localized therapy to skin. Patients with the following prior condition are excluded: - History of pancreatitis. Prior Medication: Excluded: - Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT. - Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening. Prior Treatment: Excluded: - Blood transfusion within the preceding 2 weeks. Illicit drug or alcohol abuse.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
MeriganTC, Study Chair,
Wake County Dept of Health
Raleigh, North Carolina, 27610
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Wilford Hall Med Ctr
Lackland Air Force Base, Texas, 782365300
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Brooke Army Med Ctr
San Antonio, Texas, 78284
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Walter Reed Army Med Ctr
Washington D.C., District of Columbia, 20307
United States
Fitzsimmons Army Med Ctr
Rockville, Maryland, 20850
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Natl Naval Med Ctr
Bethesda, Maryland, 208995000
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Additional Information:
Study ID Numbers: ACTG 244;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001045
Other Hiv Infections Studies:
1. A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease.
2. Genetic Markers for Focal Segmental Glomerulosclerosis
3. The Safety and Effectiveness of r-HuEPO in Patients with AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic
4. A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
5. An Electronic Pillbox for People With HIV
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients with No Symptoms of the Disease
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