A Prospective, Open-label Trial of Two ABC/3TC Based Regimens in Late Presenter naïve Patients (CD4 <200 Cells/µL)
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
1. PROTOCOL SUMMARY This is a prospective, randomized open-label, 2 arm, 3-phase trial to
compare the 48-weeks virological response of two different regimens containing
abacavir/lamivudine (abacavir/lamivudine +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine
+ raltegravir (RAL) in antiretroviral therapy naive, HIV+ individuals presenting for care
with CD4+ counts < 200/mm3.
1.1 Clinical Objectives: Primary Objective: To compare the 48-week virological response to
two different regimens containing abacavir/lamivudine (abacavir/lamivudine
+darunavir/ritonavir (DRV/r) vs abacavir/lamivudine + raltegravir (RAL) in antiretroviral
therapy naive, HIV+ individuals presenting for care with CD4+ counts < 200/mm3.
Secondary Objective: a) To compare immunological response at 48 weeks; b) To determine the
safety and tolerability of the 2 regimens.
1.2 Study population: 350 in/out patients 1.3 Outcome Primary Endpoint
- Proportion of patients with HIV RNA<50 copies/mL after 48 weeks Secondary Endpoints(s)
- Change in CD4+ cell count from baseline through week 48
- Time to virological rebound 1.4 Study design: Multicentre, parallel group, randomised,
open label, non-inferiority study 1.5 Treatment regimens: Arm A: abacavir/lamivudine 1
tablet once a day + raltegravir 400 mg (1 tablet twice a day) Arm B: abacavir/lamivudine
1 tablet once a day + ritonavir 100 mg + darunavir 800 mg once a day.
All drugs have been approved for the treatment of HIV infection. The study population will
consist of 350 HIV-positive, HLA B5701-negative patients. At baseline, patients will be
randomized 1:1 to start abacavir/lamivudine plus either raltegravir or darunavir/ritonavir.
Randomization will be stratified on the basis of the screening CD4+ cell count (≤100 vs ≥100
cells/µL), to ensure balance across treatments groups 1.7 Criteria for Safety: Adverse events
and laboratory assessments. 1.8 Statistical analysis: As this is a non-inferiority trial, we
will calculate the difference in the proportions of patients experiencing the primary outcome
in the two treatment arms and will calculate a 95% confidence interval for this.
Non-inferiority of the raltegravir arm will be demonstrated if the lower limit of the 95%
confidence interval is greater than -12%. In case non-inferiority will be met, analyses for
superiority will be performed.