A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

• Status: Completed
• Trial end date: 2000-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration.

The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.

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

Details

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

Criteria

Inclusion Criteria

Patients must have:

• HIV-1 seropositivity.

• CD4 count >= 550 cells/mm3.

• Asymptomatic disease.

• No prior antiretroviral therapy.

• Consent of parent or guardian if less than 18 years old.

PER AMENDMENT 6/18/96:

• Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Medical condition that precludes study compliance.

Concurrent Medication:

Excluded:

• Antiretrovirals other than study drugs.

• Biologic response modifiers including erythropoietin and G-CSF.

• Systemic corticosteroids.

• Systemic cytotoxic chemotherapy.

• Intravenous pentamidine.

Concurrent Treatment:

Excluded:

• Systemic radiation therapy.

Patients with the following prior conditions are excluded:

• History of grade 2 or worse peripheral neuropathy.

• History of pancreatitis or factors predisposing to pancreatitis.

Prior Medication:

Excluded:

• Prior antiretrovirals.

• Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry.

Chronic alcoholism.