Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

CompletadoFase 3ClinicalTrials.gov

ID: NCT01003990Tipo: INTERVENTIONALInicio: 1 de oct de 2002Fin estimado: 1 de feb de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Descripción detallada

Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Subjects must provide written informed consent
Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is
≤ 10,000 copies/mL while on therapy
Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor
≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)
Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied

Criterios de exclusión

WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study
WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)
Women who are pregnant or breastfeeding
Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment
All subjects previously discontinued from an atazanavir study for any reason
Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements
Any of the following laboratory values:
a) Serum creatinine ≥ 1.5 times the upper limit of normal,
b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
Hypersensitivity to any component of the formulation of study drug
Refer to Section 6.4.1 which details all prohibited therapies
Prisoners or subjects 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

Atazanavir

Tablets, Oral, 400 mg, once daily, indefinitely

drug

Atazanavir/Ritonavir

Tablets, Oral, 300/100 mg, once daily, indefinitely

drug

Tenofovir/Emtricitabine

Tablets, Oral, 300/200 mg, once daily, indefinitely

drug

Lopinavir/ritonavir

Tablets, Oral, 400/100 mg, twice daily, indefinitely

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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