NCT00084253

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Last Updated

March 5, 2010

Status Verified

June 1, 2008

Enrollment Period

2.2 years

First QC Date

June 9, 2004

Last Update Submit

March 4, 2010

Conditions

HIV Infections

Keywords

HIVTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Atazanavir/ Stavidine / Lamivudine

2

ACTIVE COMPARATOR
Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine

Interventions

Atazanavir/ Stavidine / LamivudineDRUG

Capsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks.

Also known as: Reyataz
1
Atazanavir-Ritonavir/ Stavidine / LamivudineDRUG

Capsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD\*, Once daily, 96 weeks.

Also known as: Reyataz
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent
  • HIV RNA greater than or equal 200 copies/mL at screening
  • years old or older
  • Must use barrier contraception
  • Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications

You may not qualify if:

  • 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
  • People who have a life expectancy of greater than 12 months
  • Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
  • Any antiretroviral therapy within 30 days prior to screening
  • Any prior antiretroviral therapy (greater than 30 days of NRTI and/or greater than 7 days of non-nucleoside reverse-transcriptase inhibitor (NNRTI) or protease inhibitor therapies)
  • Any of the following conditions: Cushings Syndrome, Gilbert's Syndrome, untreated hypothyroidism or hyperthyroidism, suspected primary (acute) HIV infection, obstructive liver disease, proven or suspected acute hepatitis in the 30 days prior to study entry, Intractable diarrhea (at greater than 6 loose stools per day for at least 78 consecutive days) within 30 days prior to study entry, history of hemophilia, history of acute or chronic pancreatitis, presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease
  • Active alcohol or substance abuse
  • History or signs and symptoms of bilateral peripheral neuropathy greater than grade 2 at the time of screening
  • Previous therapy with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study start or the expected need for such therapy or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4
  • Inability to swallow capsules

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Various locations within the US

Call For Information, New Jersey, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir SulfateLamivudineatazanavir, ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 9, 2004

First Posted

June 11, 2004

Study Start

June 1, 2004

Primary Completion

August 1, 2006

Last Updated

March 5, 2010

Record last verified: 2008-06

Locations

US(1)