Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

Bristol-Myers Squibb500 enrolled

Overview

This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.

Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

500

Conditions

HIV Infections

Interventions

Lamivudine/ZidovudineDRUG

Nelfinavir mesylateDRUG

StavudineDRUG

DidanosineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients may be eligible for this study if they: * Are HIV-positive. * Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3. * Are at least 18 years old. * Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms). Exclusion Criteria Patients will not be eligible for this study if they: * Have had severe diarrhea within 30 days of study entry. * Have a history of pancreatic disease or any other serious condition. * Have hepatitis within 30 days of study entry. * Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment. * Are unable to take medications by mouth. * Have received certain medications. * Are pregnant or breast-feeding.

Locations (23)

Sorra Research Ctr / Med Forum

Birmingham, Alabama, United States

Data from ClinicalTrials.gov

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