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Home > "V" Clinical Trials Conditions > Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy  Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.
Details: Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone. Patients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDMENT 8/27/96: The study has been extended 6 months and treatment will be available until March 15, 1997 at the latest. Each patient will have regularly scheduled 12 week safety visits during the extension period. AS PER AMENDMENT 1/22/97: The study has been extended for approximately 16 additional weeks beyond the current 6-month extension. Subjects will be unblinded to their assigned regimen beginning 2/21/97 and will continue therapy for up to 16 weeks in open-label fashion. AS PER AMENDMENT 5/9/97: The study has been extended for an additional 8 weeks; study drug will not be provided after 9/15/97.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis in patients with CD4 count <= 200 cells/mm3. Allowed: - Chemophylaxis against Mycobacterium tuberculosis. - Acyclovir. - Vaccination with pneumococcal vaccine polyvalent. - Haemophilus B Conjugate vaccine. - Chemoprophylaxis for MAC and Toxoplasma gondii. - Antibiotics. - Recombinant erythropoietin ( EPO ) and G-CSF. - Systemic corticosteroids for < 21 days. - Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives. - Vitamins and herbal therapies. Concurrent Treatment: Allowed: - Limited local radiation therapy to skin. - Blood transfusions if 3 units or less per 21-day period. - Acupuncture. - Visualization techniques. Patients must have: - Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval. - Not reached an ACTG 175 endpoint prior to May 1, 1995. - Consent of parent or guardian if less than 18 years old. PER AMENDMENT 8/27/96: - Patients must be on study/on treatment at the time the protocol study treatment is extended. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Grade 2 or worse peripheral neuropathy. - Malignancy requiring systemic therapy. Concurrent Medication: Excluded: - Anti-HIV drugs other than study drugs. - Biologic response modifiers. - Systemic cytotoxic chemotherapy. - Any drug known to affect glucuronidation and/or clearance of AZT. Concurrent Treatment: Excluded: - Radiation therapy other than limited local therapy to skin. Patients with the following prior condition are excluded: - History of acute or chronic pancreatitis. Prior Medication: Excluded: - Prior 3TC. - Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry. Current ethanol abuse.
Total Enrollment: 280
Location and Contact Information:
Overall Study Official:
KatzensteinD, Study Chair,
Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick, New Jersey, 08903
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
United States
Michigan State Univ Hemophilia Comprehensive Care Clinic
Lansing, Michigan, 48912
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605
United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York City, New York, 10029
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Great Plains - Hemophilia / Univ of Iowa Hosp & Clinic
Iowa City, Iowa, 52242
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: ACTG 302;
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000831
Other Hiv Infections Studies:
1. Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected with HIV
2. Safety of the Candidate Vaccine C4-V3 Alone or with Interleukin-12 (IL-12) in HIV-Infected Patients Receiving Effective Anti-HIV Drug Therapy
3. Aerosols in the Treatment of Asymptomatic Pneumocystis Pneumonia: A Pilot Study Assessing the Effectiveness of Aerosolized Pentamidine as Treatment of Subclinical Pneumocystis Infection in Patients With No Clinical Symptoms
4. A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy
5. A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
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