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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00084253
First received: June 9, 2004
Last updated: March 4, 2010
Last verified: June 2008

June 9, 2004
March 4, 2010
June 2004
August 2006   (final data collection date for primary outcome measure)
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).
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Complete list of historical versions of study NCT00084253 on ClinicalTrials.gov Archive Site
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Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients

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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Atazanavir/ Stavidine / Lamivudine
    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.
    Other Name: Reyataz
  • Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine
    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.
    Other Name: Reyataz
  • Active Comparator: 1
    Intervention: Drug: Atazanavir/ Stavidine / Lamivudine
  • Active Comparator: 2
    Intervention: Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed Informed Consent
  • HIV RNA greater than or equal 200 copies/mL at screening
  • 18 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00084253
AI424-089 ST
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Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP