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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

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A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

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