Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine
2 other identifiers
interventional
300
2 countries
18
Brief Summary
To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
April 1, 1992
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 5, 2011
August 1, 2011
November 2, 1999
August 4, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed for Hematologic toxicity:
- Erythropoietin.
- Colony-Stimulating Factors.
- Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP):
- Aerosolized pentamidine.
- Trimethoprim/sulfamethoxazole.
- Dapsone.
- NOTE:
- If intravenous pentamidine is required for treatment of PCP, study drug should be suspended until one week after completion of intravenous pentamidine.
- Allowed:
- Prophylactic or suppressive therapy begun prior to study entry with the exception of neurotoxic agents (as defined in the protocol).
- Concurrent Treatment:
- Allowed:
- Transfusions for hematologic toxicity.
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Active acute AIDS defining infection.
- Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis.
- Dementia of such severity that patient cannot give informed consent.
- Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg).
- Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy.
- Extensive Kaposi's sarcoma or other malignancy requiring systemic cytotoxic myelosuppressive or neurotoxic chemotherapy.
- Cardiomyopathy or the need for antiarrhythmic therapy.
- Inability to tolerate at least 600 mg per day of zidovudine (AZT).
- Seizures within the last 6 months or the need for anticonvulsant therapy.
- Concurrent Medication:
- Excluded:
- Ganciclovir (DHPG).
- Myelosuppressive or neurotoxic chemotherapy.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
Yale Univ Med School
New Haven, Connecticut, 06510, United States
G E Morey Jr
Fort Lauderdale, Florida, 33316, United States
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, 32806, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Edward Hines Veterans Administration Hosp
Hines, Illinois, 60141, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Harper Hosp
Detroit, Michigan, 48201, United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203, United States
Med College of Ohio
Toledo, Ohio, 43699, United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Dr Stephen L Green
Hampton, Virginia, 23666, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226, United States
UPR School of Medicine
San Juan, 009275800, Puerto Rico
Related Publications (1)
Ruedy N, et al. Results of long term follow-up of a double blind study of ddI vs continued AZT among individuals with CD4s 200-500/mm3. Int Conf AIDS. 1994 Aug 7-12;10(2):16 (abstract no 358B)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb