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A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects


Phase 3
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects


Inclusion Criteria:



- HIV RNA ≥5000 c/ml

Exclusion Criteria:

- Any antiretroviral therapy within 30 days prior to screening;

- Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable
method to avoid pregnancy for the entire study and for up to 8 weeks after the study;

- WOCBP using a prohibited contraceptive method

- WOCBP who are pregnant or breastfeeding;

- Women with a positive pregnancy test on enrollment or prior to study drug
administration;

- Presence of a newly diagnosed HIV-Related opportunistic infection or any medical
condition requiring acute therapy at the time of enrollment;

- Suspected primary (acute) HIV infection;

- Prior antiviral therapy (>30 days of NRTI and/or >7 days of non-nucleoside reverse
transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within
30 days prior to screening; some exceptions are allowed for ARV therapy in use for
Mother-to-child transmission;

- Participants with Cushing's syndrome;

- Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a
stable replacement dose of thyroid hormone is acceptable provided the thyroid
stimulating hormone (TSH) performed within 30 days of screening is within normal drug
range;

- Recent therapy with agents with significant systemic myelosuppressive, neurotoxic,
pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or
expected need for such therapy at the time of enrollment; or therapy with methadone
or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect
CYP3A4;

- Participants with obstructive liver disease;

- Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent
adequate compliance with study therapy or to increase the risk of developing
pancreatitis or chemical hepatitis;

- Proven or suspected acute hepatitis in the 30 days prior to study entry;

- Intractable diarrhea (≥6 loose stools/day for at least 7 consecutive days) within 30
days prior to study entry;

- Inability to swallow capsules;

- Active peripheral neuropathy;

- Presence of cardiomyopathy (due to any cause) or any significant cardiovascular
disease, such as unstable ischemic heart disease;

- Known, clinically significant cardiac conduction system disease.

- Baseline laboratory values measured within 2 weeks prior to initiating study drugs as
follows:

1. calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault
equation;

2. total serum lipase ≥ 1.4 times the upper limit of normal;

3. liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal;

4. total serum bilirubin ≥ 1.5 times the upper limit of normal.

- Hypersensitivity to any component of the formulation of study drug;

- Prohibited therapies;

- Any other clinical conditions or prior therapy that, in the opinion of the
Investigator, would make the participant unsuitable for study or unable to comply
with the dosing requirements;

- Prisoners or participants who are compulsorily detained (involuntarily incarcerated)
for treatment of either a psychiatric or physical (e.g., infectious disease) illness
must not be enrolled into this study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48

Outcome Description:

HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.

Outcome Time Frame:

Baseline (Day 1) and Week 48

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

AI424-138

NCT ID:

NCT00272779

Start Date:

November 2005

Completion Date:

October 2008

Related Keywords:

  • HIV Infections
  • HIV
  • Treatment Naive
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWilmington, North Carolina  
Local InstitutionAustin, Texas