A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection

CompletadoFase 2ClinicalTrials.gov

ID: NCT00004852Tipo: INTERVENTIONALInicio: 1 de sept de 1999

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.

Descripción detallada

Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients may be eligible for this study if they:
Are 18 years of age or older.
Are HIV-positive.
Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).

Criterios de exclusión

Patients will not be eligible for this study if they:
Have taken any antiretroviral (anti-HIV) agent.
Are pregnant or breast-feeding.
Are unable to absorb food or have trouble taking medicines by mouth.
Abuse alcohol or drugs to an extent that may make study participation difficult.
Are not likely to be able to complete the 48 weeks of study treatment.
Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
Have received an investigational vaccine within the past 3 months or have received gene therapy.
Have a severe medical condition such as diabetes or heart trouble.
Have been diagnosed with AIDS.
Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
Are taking medications that affect the immune system within 30 days of study entry.
Are taking medications that may interact with the study drugs.

Intervenciones

drug

Efavirenz

drug

Lamivudine

drug

Zidovudine

Ubicaciones

Hosp Muniz

Buenos Aires, Argentina

CAICI

Rosario - Santa Fe, Argentina

Patrocinadores

PrincipalGlaxo Wellcome

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