Resumen

El propósito de este estudio es evaluar la eficacia antiviral, la seguridad y la tolerabilidad de la terapia dual con 3TC y DTG como tratamiento inicial en pacientes con VIH sin tratamiento previo.

Descripción detallada

El propósito de este estudio es comparar la eficacia antiviral, la seguridad y la tolerabilidad de la terapia dual con 3TC y DTG como tratamiento inicial en pacientes con VIH sin tratamiento previo. Los datos recopilados en este estudio contribuirán al diseño de estudios más amplios destinados a evaluar la seguridad metabólica y a largo plazo, el impacto sobre los biomarcadores inflamatorios, la eficacia, la seguridad y la rentabilidad de esta estrategia en pacientes sin tratamiento previo y con supresión viral. Criterio de valoración primario: proporción de pacientes con niveles de ARN del VIH-1 inferiores a 50 copias/mL en la semana 48. Criterios de valoración secundarios: frecuencia, tipo y gravedad de los eventos adversos y las anomalías de laboratorio; proporción de pacientes con ARN del VIH-1 <1000 copias/mL en la semana 12; proporción de pacientes con ARN del VIH <400 en la semana 24; número y tipo de mutaciones de resistencia en caso de fracaso virológico (definido como carga viral confirmada superior a 400 copias/mL después de la semana 24 o rebote viral en cualquier momento); cambios en el recuento de linfocitos CD4+ entre el período basal y la semana 48; estimación de la reducción viral en comparación con datos históricos.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

\> 18 years of age
Documented HIV-1 infection (positive ELISA plus a confirmatory Western Blot; or plasma HIV-1 RNA ≥10,000 copies/mL)
Voluntarily signed and dated , IRB / IEC approved informed consent form
Agrees not to take any other medication during the study
Screening HIV RNA \>5,000 copies/mL and ≤ 100,000 copies/ml
Naïve to ARV therapies
CD4 ≥200 cells/mL
Subjects can comply with protocol requirements
Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial
Patient is a male or a female not breastfeeding or pregnant
A female, may be eligible if she:
is of non-child-bearing potential
is of child-bearing potential with a negative pregnancy test at Screening and Day 1 and agrees to use one of the following methods:
Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after
Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
IUD and male condom
Male partner sterilization confirmed and male condom
Approved hormonal contraception and male condom
Any other method with published data showing that the expected failure rate is \<1% per year and use male condom
Any contraception method must be used for at least 2 weeks after discontinuation of IP

Criterios de exclusión

\. Genotypic resistance to lamivudine at screening,as per IAS -USA Panel 2013 2. Alcohol or drug use that might impact on adherence 3. Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study 4. Lactating, pregnancy or fertile women willing to be pregnant 5. Concomitant use of lowering lipid drugs, interferon, interleukin-2, cytotoxic chemotherapy, Dofetilide (or pilsicainide ) or immunosuppressors at study entry 6. Grade 4 lab abnormalities 7. Primary HIV infection (indeterminate WB or previous negative HIV in the last 6 months.) 8. Opportunistic infection (CDC C category) or other disease and/or clinical condition that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia 9. Subjects who in the investigator's judgment, poses a significant suicidality risk 10. History or presence of allergy to the study drugs or their components or drugs of their class 11. Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product 12. Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound 13. Alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \>35% direct bilirubin) 14. Creatinine clearance of \<50 mL/min via Cockcroft-Gault method 15. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
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Dolutegravir-lamivudina como terapia dual en pacientes con infección por VIH-1 sin tratamiento previo: un estudio piloto

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

dolutegravir, lamivudine

Ubicaciones

Fundacion Huesped

Patrocinadores