Completed

A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

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What is being tested

Lopinavir/Ritonavir

+ Nelfinavir mesylate

+ Lamivudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorAbbott
Last updated: February 20, 2009
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors. Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.

NCT00004583
Principal SponsorAbbott
Last updated: February 20, 2009
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

660 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 12 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 You may be eligible for this trial if you: Are HIV positive. Have a viral load (level of HIV in your blood) of more than 400 copies/ml. Are age 12 or older. Agree to practice abstinence or use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this trial if you: Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC. Are seriously ill or have an AIDS-related infection. Are pregnant or breast-feeding. Are taking certain medications.

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 83 locations

Pacific Oaks Med Group

Beverly Hills, United StatesOpen Pacific Oaks Med Group in Google Maps

Orange County Ctr for Special Immunology

Fountain Valley, United States

AIDS Healthcare Foundation

Los Angeles, United States

Tower ID Med Associates

Los Angeles, United States
Completed83 Study Centers