Completed

Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients

What is being tested

Atazanavir/ Stavidine / Lamivudine

+ Atazanavir-Ritonavir/ Stavidine / Lamivudine

Drug

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: June 2004

See protocol details

Summary

Principal SponsorBristol-Myers Squibb

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.

Official TitlePhase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients

NCT00084253

Principal SponsorBristol-Myers Squibb

Last updated: January 27, 2026

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

200 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, ViralHIV InfectionsLentivirus Infections

Criteria

5 inclusion criteria required to participate

Signed Informed Consent

HIV RNA greater than or equal 200 copies/mL at screening

18 years old or older

Must use barrier contraception

Show More Criteria

12 exclusion criteria prevent from participating

Any antiretroviral therapy within 30 days prior to screening

Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study

Women using oral contraceptives, pregnant or breastfeeding women

Women who have a positive pregnancy test on enrollment or before beginning to take the study medications

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Study Objectives

Primary Objectives

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 1 location

Suspended

Various locations within the US

Call For Information, United StatesOpen Various locations within the US in Google Maps

CompletedOne Study Center