A Prospective, 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)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by University of Modena and Reggio Emilia
Sponsor:
Information provided by (Responsible Party):
Cristina Mussini, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01900106
First received: July 5, 2013
Last updated: July 11, 2013
Last verified: July 2013

July 5, 2013
July 11, 2013
July 2013
December 2014   (final data collection date for primary outcome measure)
HIV RNA Viral Load [ Time Frame: baseline and week 48 ] [ Designated as safety issue: No ]
The proportion of patients attaining an HIV RNA level <50 copies/mL after 48 weeks will be the primary outcome.
Same as current
Complete list of historical versions of study NCT01900106 on ClinicalTrials.gov Archive Site
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A Prospective, 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)
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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:

  1. To compare immunological response at 48 weeks;
  2. To determine the safety and tolerability of the 2 regimens. 1.2 Study population: 350 inpatients or outpatients will be randomized 1.3 Outcome Primary Endpoint

    • Proportion of patients with undetectable viremia (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 Safety endpoints
    • Incidence of adverse events (AEs)
    • Incidence of serious adverse events (SAEs)
    • Discontinuations due to adverse events
    • Incidence of grade 3 or 4 laboratory abnormalities. 1.4 Study design Multicentre, parallel group, randomised, open label, non-inferiority study 1.5 Planned sample size: The planned sample size for this trial is 350 patients 1.6 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. Administration: oral 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.

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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: abacavir/lamivudine + raltegravir
  • Drug: abacavir/lamivudine + darunavir/ritonavir
  • Experimental: abacavir/lamivudine + raltegravir
    abacavir/lamivudine + raltegravir
    Intervention: Drug: abacavir/lamivudine + raltegravir
  • Active Comparator: abacavir/lamivudine + darunavir/ritonavir
    abacavir/lamivudine + darunavir/ritonavir
    Intervention: Drug: abacavir/lamivudine + darunavir/ritonavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
350
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December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males or females (inpatients or outpatients) 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.

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.
Both
18 Years to 64 Years
No
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NCT01900106
RTLP, 2011-005973-21
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Cristina Mussini, University of Modena and Reggio Emilia
University of Modena and Reggio Emilia
Not Provided
Not Provided
University of Modena and Reggio Emilia
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP