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Home > "A" Clinical Trials Conditions > A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3. Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
Details: Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs. Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly with ddI will start with AZT, while the other half will start with ddI. Treatment continues until death or termination of the study. Patients are followed every 4 weeks. The study will include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic assessments will be made.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis. Allowed: - Erythropoietin. - Prophylaxis for MAI or fungal infections. - Antibiotics. - Over-the-counter, alternative, or regularly prescribed drugs. - Steroids, if for < 21 days. Concurrent Treatment: Allowed: - Radiation therapy for cutaneous Kaposi's sarcoma. Patients must have: - HIV infection. - CD4 count <= 50 cells/mm3. - Prior nucleoside monotherapy for at least 6 months. - Life expectancy of at least 6 months. Prior Medication: Required: - Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Severe peripheral neuropathy. - Psychological or emotional problems sufficient to prevent study compliance. Concurrent Medication: Excluded: - Systemic chemotherapy for malignancy. - Acute or induction therapy for opportunistic infection. Patients with the following prior conditions are excluded: - History of acute or chronic pancreatitis. - Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. Prior Medication: Excluded: - Non-study nucleosides or biologic response modifiers within 7 days prior to study entry. - Acute therapy for opportunistic process within 14 days prior to study entry. - Acute systemic therapy for other medical conditions within 14 days prior to study entry.
Total Enrollment: 654
Location and Contact Information:
Overall Study Official:
WKHenry, Study Chair,
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Whitman - Walker Clinic / Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
HIV Ctr - District of Columbia Gen Hosp
Washington D.C., District of Columbia, 200072197
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: ACTG 193;
Study Start Date:
Record last reviewed: January 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001029
Other Hiv Infections Studies:
1. The Effects of Anti-HIV Therapy on the Immune Systems of Children Infected With HIV
2. Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces boulardii or Placebo: A Double Blind Trial
3. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
4. Emotional Disclosure in HIV
5. Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals
Related Studies:
Other HIV Infections Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
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