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)

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) - RTLP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005973-21-IT

Enrollment

350

Registered

2012-03-07

Start date

2013-11-20

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced HIV disease, defined as a CD4 cell count <200 cells/µL or the presence of an AIDS-defining event. MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: KIVEXA*FL 30CPR RIV 600MG+300M Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ABACAVIR SULFATE CAS Number: 188062-50-2 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males or females aged 18-64 years who are HIV-1 antibody seropositive, with a CD4 count 9.0 grams/dl (men and women) Platelet count = 75,000 cells/mm3 Alkaline phosphatase =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Proportion of patients with undetectable viremia (HIV-1 RNA50 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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactClinica Malattie Infettive

Universita' degli Studi di Modena e Reggio Emilia

nb.protocolli@unimore.it+39 059 422 3673

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026