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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2000-02-29

Brief Summary

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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.

Detailed Description

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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.

Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks.

PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.

Conditions

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HIV Infections

Keywords

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Didanosine Drug Therapy, Combination Zidovudine Drug Administration Schedule

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Zidovudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Collier AC

Role: STUDY_CHAIR

Johnson V

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Site Status