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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002035

Run by

Bristol-Myers Squibb

People needed

300

Expected to finish

1992-04-01

Last updated by the study team

2011-08-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Antiarrhythmic therapy.
• Anticonvulsant therapy.
• Neurotoxic agents (as defined in the protocol).
• NOTE:
• If intravenous pentamidine is required for treatment of Pneumocystis carinii pneumonia (PCP), study drug should be suspended until 1 week after completion of intravenous pentamidine.
• Patients with the following are excluded:
• Symptoms and conditions defined in the Patient Exclusion Co-Existing Conditions field.
• Average of two sequential CD4 counts from SciCor Clinical Laboratories in the 30 days prior to study entry > 300 cells/mm3.
• Prior Medication:
• Excluded, participation in studies using:

Where it is running

• Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• G E Morey Jr — Fort Lauderdale, Florida, United States
• VP Med Services / HHCS Research Institute Inc — Orlando, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Edward Hines Veterans Administration Hosp — Hines, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Harper Hosp — Detroit, Michigan, United States
• Albany Med College / AIDS Treatment Ctr — Albany, New York, United States
• Med College of Ohio — Toledo, Ohio, United States
• Univ of Pennsylvania / HIV Clinic — Philadelphia, Pennsylvania, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States
• Audie L Murphy Veterans Administration Hosp — San Antonio, Texas, United States
• Univ of Utah School of Medicine — Salt Lake City, Utah, United States
• Dr Stephen L Green — Hampton, Virginia, United States
• Milwaukee County Med Complex — Milwaukee, Wisconsin, United States
• UPR School of Medicine — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.