A prospective, randomized, open-label trial of two abacavir/lamivudine based regimen (ABC/3TC + darunavir/ritonavir or ABC/3TC + raltegravir) in late presenter naïve patients (with CD4 count <200 cells/µL - advanced HIV disease)

Conditions: Advanced HIV disease, defined as a CD4 cell count <200 cells/µL or the presence of an AIDS-defining event.
MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-005973-21-IT

Lead Sponsor: AZIENDA OSPEDALIERA POLICLINICO DI MODENA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Males or females aged 18-64 years who are HIV-1 antibody seropositive, with a CD4 count <200 cells/uL. 2. All patients should be antiretroviral-naive 3. All patients should be HLA B57 or HLA B5701 negative 4. Patients must have an HIV RNA level <500,000 copies/mL 5. Patients with an active opportunistic infection could be enrolled as long as this was diagnosed more than 2 weeks prior to screening. 6. Patients must meet the following laboratory criteria. Neutrophil count ? 1,000 cells/mm3 Haemoglobin > 9.0 grams/dl (men and women) Platelet count = 75,000 cells/mm3 Alkaline phosphatase < 3.0 the upper limit of normal ALT and AST < 3.9 times the upper limit of normal Total bilirubin < 1.5 times the upper limit of normal. 7. Female patients of childbearing potential must be willing to use a reliable form of contraception, which will include a medically approved form of barrier contraception. 8. Patients must be able to provide written consent to comply with study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with genotypic mutations for any of the study drugs. 2. Patients with an opportunistic infection diagnosed in the 2 weeks prior to screening. 3. Female patients who are pregnant or breastfeeding. 4. Patients who are receiving any investigational drug or anti-neoplastic radiotherapy/chemotherapy other than local skin radiotherapy within 12 weeks before randomization. 5. Patients with a current history of intravenous drug abuse, alcohol or substance abuse.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Proportion of patients with undetectable viremia (HIV-1 RNA<50 copies/mL) after 48 weeks;Secondary Objective: Change in CD4+ cell count from baseline through week 48; Time to virological rebound, defined as plasma HIV RNA >50 copies/mL measured on two consecutive occasions at least one month apart.;Primary end point(s): Proportion of patients with undetectable viremia (HIV-1 RNA<50 copies/mL) after 48 weeks;Timepoint(s) of evaluation of this end point: 48 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to virological rebound, defined as plasma HIV RNA >50 copies/mL measured on two consecutive occasions at least one month apart.;Timepoint(s) of evaluation of this end point: 48 weeks