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

NCT ID: NCT00002035

Last Updated: 2011-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1992-04-30

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Zidovudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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

Countries

United States; Puerto Rico

References

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)

Reference Type: BACKGROUND

Other Identifiers

AI454-010

Identifier Type: -

Identifier Source: secondary_id

039B

Identifier Type: -

Identifier Source: org_study_id