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

Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002429

Enrollment

500

Registered

2001-08-31

Start date

1999-07-31

Completion date

2001-01-31

Last updated

2011-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Didanosine, Drug Therapy, Combination, Stavudine, RNA, Viral, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Brief summary

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.

Detailed description

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.

Interventions

DRUGLamivudine/Zidovudine

DRUGNelfinavir mesylate

DRUGStavudine

DRUGDidanosine

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026