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
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Zidovudine (Drug); Didanosine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Clinical Details
Official title: 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
Study design: Treatment, Double-Blind, Safety Study
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
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:
- Dideoxyinosine (ddI).
- 2',3'-Dideoxy-2',3'-didehydrothymidine (d4T).
- Dideoxycytidine (ddC).
- Excluded within one month of study entry:
- Any other experimental antiretroviral compounds.
Patients must:
- Have documented HIV positivity via ELISA.
- Meet CDC criteria for AIDS or AIDS related complex (ARC).
- Have received zidovudine (AZT) for = or > 6 months and tolerated a dose of at least
500 mg per day without significant hematologic toxicity.
- Have no acute AIDS defining opportunistic infection, but may be receiving suppressive
therapy for such infections.
- Demonstrate at least one of the following criteria for clinical deterioration despite
AZT therapy within 4 weeks prior to study entry (8 weeks prior for weight loss):
- involuntary weight loss of more than 5 percent of the body weight occurring over the 8
week period prior to study entry, Karnofsky score = or > 50 but demonstrating a fall =
or > 20 from previous level of functioning (assessment must be persistent on two
occasions at least 14 days apart), unexplained fever of = or > 38 degrees C (despite
evaluation defined in protocol) for more than 7 days, appearance of newly diagnosed
oral hairy leukoplakia or oral candidiasis, or recurrence of a previously quiescent
multidermatomal varicella-zoster, appearance of dermatologic afflictions (e. g.
psoriasis, molluscum contagiosum, or newly diagnosed seborrheic dermatitis),
appearance of chronic herpetic ulcers not responsive to acyclovir therapy.
Required:
- Zidovudine (AZT) for = or > 6 months prior to study entry.
Locations and Contacts
UPR School of Medicine, San Juan 009275800, Puerto Rico
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
Audie L Murphy Veterans Administration Hosp, San Antonio, Texas 78284, United States
Univ TX Galveston Med Branch, Galveston, Texas 775550882, 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
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Related publications: 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)
Last updated: October 1, 2007
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