Dolutegravir HIV-1 viral decay and pharmacokinetics in semen in ARV-naïve patients initiating Abacavir/Lamivudine plus Dolutegravir. - VIDEOS

nidad de VIH - Servicio de Enfermedades Infecciosas. Hospital de Bellvitge0 个研究点开始时间: 2013年11月12日最近更新: 2014年12月8日

试验速览

暂无简介。

•1 Male patients
•2 Age equal or greater than 18 years old
•3 Chronic HIV-1 infection
•4 ART-naïve patients
•5 Viral load (HIV-1 RNA) > 5000 copies/mL at the baseline visit
•6 HLA-B*5701 test negative
•7 Signature of the Informed Consent Form previously to the patient inclusion in the study
•8. Patients must agree to use an effective method of contraception during heterosexual intercourse throughout the study period and for 30 days after the end of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1 Chronic Hepatitis B serum markers at the baseline visit (HbsAg+);
•2. Chronic Hepatitis C that anticipated need of treatment during the course of the study
•3 Severe hepatic inufficiency
•4 Renal insufficiency: Estimated glomerular filtrate (MDRD)<60mL/min
•5 Active opportunistic infection.
•6 Active neoplasm.
•7 Documented HIV-1 primary resistance to the study antriretroviral drugs, in basal genotype test.
•8 Presence of any Grade IV laboratory abnormality in the laboratory tests performed at the baseline visit.
•9 AST or ALT = 3 times the upper normal limit; and/or bilirrubin =1.5 times the upper normal limit

发起方

nidad de VIH - Servicio de Enfermedades Infecciosas. Hospital de Bellvitge