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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 Institution Phoenix, Arizona  
Local Institution Corona, California  
Local Institution Washington, District of Columbia  
Local Institution Fort Lauderdale, Florida  
Local Institution Wilmington, North Carolina  
Local Institution Austin, Texas