A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

• Status: Completed
• Trial end date: 1995-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Bristol-Myers Squibb
• Treatments: Didanosine; Zidovudine

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).

• Immunoglobulin.

• Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.

Concurrent Treatment:

Allowed:

• Blood transfusions.

Prior Medication:

Allowed:

• Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).

Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.

• Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.

• Patient or guardian available to give written informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded.

• Hypersensitivity to didanosine (ddI).

• Symptomatic cardiomyopathy.

• Seizures that are not well controlled by ongoing anticonvulsant therapy.

• Symptomatic pancreatitis.

• Grade 1 or higher peripheral neuropathy.

• Active malignancy requiring chemotherapy.

Concurrent Medication:

Excluded:

• Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.

Avoid:

• Drugs with potential to cause peripheral neuropathy or pancreatitis.

Patients with the following are excluded:

• Active malignancy requiring concomitant chemotherapy.

Prior Medication:

Excluded:

• Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.

• Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.

• Any other experimental therapy within 1 week of entry.

• Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.