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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00272779Tipo: INTERVENTIONALInicio: 1 de nov de 2005Fin estimado: 1 de oct de 2008

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

HIV RNA ≥5000 c/ml

Criterios de exclusión

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:
calculated creatine clearance \<60 mL/min as estimated by the Cockcroft-Gault equation;
total serum lipase ≥ 1.4 times the upper limit of normal;
liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal;
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.

Intervenciones

drug

ATV

300mg Oral capsules for 96 weeks

drug

RTV

100mg Oral Capsules for 96 weeks

drug

Tenofovi-Emtricitabine (TDF/FTC) tablet

One tablet with 300 mg - 200 mg once a day for 96 weeks.

drug

LPV

400 mg (3 133mg capsules) BID for 96 weeks

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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