A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
NCT ID: NCT00001029
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
654 participants
INTERVENTIONAL
1993-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Zidovudine
Zalcitabine
Didanosine
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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WK Henry
Role: STUDY_CHAIR
JO Kahn
Role: STUDY_CHAIR
HH Balfour
Role: STUDY_CHAIR
Locations
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USC CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
San Mateo County AIDS Program
San Mateo, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Northwestern University CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
Minneapolis, Minnesota, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Cornell University A2201
New York, New York, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
Mbeya, , Tanzania
Countries
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References
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Fichtenbaum CJ, Powderly WG. Refractory mucosal candidiasis in patients with human immunodeficiency virus infection. Clin Infect Dis. 1998 Mar;26(3):556-65. doi: 10.1086/514571.
Henry K, Tierney C, Kahn J, Balfour H, Jiang Q, Kmack A, Fischl M. A randomized, double-blind, placebo-controlled study comparing combination nucleoside and triple therapy for the treatment of advanced HIV disease (CD4 less than or equal to 50/mm(3)). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:207 (abstract no LB6)
Henry K, Erice A, Tierney C, Balfour HH Jr, Fischl MA, Kmack A, Liou SH, Kenton A, Hirsch MS, Phair J, Martinez A, Kahn JO. A randomized, controlled, double-blind study comparing the survival benefit of four different reverse transcriptase inhibitor therapies (three-drug, two-drug, and alternating drug) for the treatment of advanced AIDS. AIDS Clinical Trial Group 193A Study Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Dec 1;19(4):339-49. doi: 10.1097/00042560-199812010-00004.
Other Identifiers
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11168
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 193
Identifier Type: -
Identifier Source: org_study_id