A Randomised, Controlled, Open-Label, 48-Week, Study To Asses Differences in Changes In Plasma Lipid Profile Between Patients On Saquinavir/Ritonavir Or Atazanavir/Ritonavir In Combination With Tenofovir Disoproxil Fumarate And Emtricitabine As A First-line Regimen.BASIC (Boosted Atazanavir or Saquinavir Induced Lipid Changes) - BASIC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

•Provide written informed consent.
•HIV-1 infected patients.
•At least 18 years of age.
•Males or non-pregnant, non-lactating females.
•Anti-retroviral treatment naive.
•Indication for antiretroviral therapy according to current treatment guidelines.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•CD4 count > 350 cells/mm3,, except in case of symptomatic HIV disease and/or an AIDS-defining illness.
•HIV-2 co-infection.
•Use of co-medication with a known or suspected pharmacological interaction which precludes the appropriate use of one or more of the study drugs.
•Anticipated non-compliance with the protocol.
•Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study. Women who are pregnant, or have the intention to become pregnant during the study period.
•Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs. Chronic hepatitis C is allowed, provided that treatment for hepatitis C is not anticipated during the study period.
•Clinically relevant laboratory abnormalities: anaemia, thrombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase, which in the opinion of the investigator is a contraindication for the use of any of the study drugs.
•Significant renal dysfunction (creatinine clearance [CrCl] <60 mL/min) and/or hepatic impairment (aspartate aminotransferase/ alanine aminotransferase [AST/ALT] >3 X ULN and/or documented liver cirrhosis)
•Use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate and any other of the study drugs.
•Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period.
•Patients who have taken any investigational drug 30 days prior to the start of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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