Completed

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

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What is being tested

Lamivudine/Zidovudine

+ Nelfinavir mesylate

+ Stavudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 1999
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: May 4, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00002429
Principal SponsorBristol-Myers Squibb
Last updated: May 4, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Sorra Research Ctr / Med Forum

Birmingham, United StatesOpen Sorra Research Ctr / Med Forum in Google Maps

Body Positive

Phoenix, United States

AIDS Healthcare Foundation

Los Angeles, United States

San Francisco Gen Hosp

San Francisco, United States
Completed23 Study Centers