Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Eurotrials, Scientific Consultants
Information provided by:
Doroana, Maria Manuela, M.D.
ClinicalTrials.gov Identifier:
NCT01190124
First received: August 25, 2010
Last updated: April 20, 2011
Last verified: April 2011

August 25, 2010
April 20, 2011
April 2010
July 2010   (final data collection date for primary outcome measure)
  • HIV-RNA Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
  • HIV-RNA Levels [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  • HIV-RNA Levels [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  • CD4 Cells Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    CD4 cells count at baseline.
  • CD4 Cells Count [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    CD4 cells count at week 24.
  • CD4 Cells Count [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    CD4 cells count at week 48.
  • HIV-RNA levels [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    - Proportion of patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  • HIV-RNA levels [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    - Proportion of patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  • CD4 cells count [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    - Mean changes of CD4 cells count at week 24.
  • CD4 cells count [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    - Mean changes of CD4 cells count at week 48.
Complete list of historical versions of study NCT01190124 on ClinicalTrials.gov Archive Site
  • HIV-RNA Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
  • HIV-RNA Levels [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  • HIV-RNA Levels [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  • CD4 Cells Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.
  • CD4 Cells Count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.
  • CD4 Cells Count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.
  • CD4 Cells Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients CD4 cells count will be assessed at baseline.
  • CD4 Cells Count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients CD4 cells count will be assessed at week 24.
  • CD4 Cells Count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients CD4 cells count will be assessed at week 48.
  • HIV-RNA Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
  • HIV-RNA Levels [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  • HIV-RNA Levels [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  • Adverse Drug Reactions [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
    Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.
  • HIV-RNA levels [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be determined the proportion that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  • CD4 cells count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be assessed the mean changes of CD4 cells count at week 24.
  • HIV-RNA levels [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be determined the proportion that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  • CD4 cells count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For patients in whom T20 was replaced by raltegravir it will be assessed the mean changes of CD4 cells count at week 48.
  • HIV-RNA levels [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients it will be determined the proportion of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  • CD4 cells count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients it will be assessed the mean changes of CD4 cells count at week 24.
  • HIV-RNA levels [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients it will be determined the proportion of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  • CD4 cells count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    For the HIV-2 infected patients it will be assessed the mean changes of CD4 cells count at week 48.
  • HIV-RNA levels [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Proportion of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24 per OBT
  • CD4 cells count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Mean changes of CD4 cells count at week 24 by OBT
  • HIV-RNA levels [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Proportion of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48 per OBT.
  • CD4 cells count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Mean changes of CD4 cells count at week 48 by OBT.
  • Adverse Drug Reactions [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
    Incidence of clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.
  • Lab abnormalities [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
    To compare the proportion of Grade 3/4 hepatic toxicity and lab abnormalities in HIV-1 co-infected patients (HCV and/or HBV) vs non co-infected.
Not Provided
Not Provided
 
Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients
Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients: a Retrospective Analysis of a Portuguese Cohort Treated Within the Expanded Access Program

The purpose of this study is to evaluate the efficacy of raltegravir with optimized background therapy (OBT) in multiple-experienced HIV infected patients, measured by the proportion of patients with undetectable viral load and the mean increase of CD4 cells count at week 24 and 48.

It is also intended to evaluate:

  • viral load suppression and the mean increase of CD4 cells count at week 24 and 48 in patients who needed to change antiretroviral (ARV) therapy due to inacceptable toxicity, as determined by the investigator, including patients who needed to replace T20.
  • efficacy of raltegravir with OBT in HIV-2 infected patients that were included in this cohort, measured by the percentage of patients with undetectable viral load and the mean change of CD4 cells count at week 24 and 48.

Study hypotheses:

  • Raltegravir with OBT is effective in achieving and maintaining a long term virologic suppression along with a significant increase on CD4 cells count in both HIV-1 and HIV-2 infected patients.
  • Patients who replaced T20 by raltegravir, due to intolerance, are able to maintain long term virologic suppression.

Considering its novel mechanism of action, potency, safety and tolerability, and pharmacokinetic profile, raltegravir has been used in several clinical scenarios. Since its initial clinical use in multiresistant patients throughout the Expanded Access and Compassionate Use Program (started in March 2007) raltegravir has been used successfully in other clinical scenarios, including but not limited to: enfuvirtide-related serious adverse events and intolerance, nucleoside analogue inhibitors' toxicity, ritonavir and protease inhibitor intolerance and to avoid significant drug-drug interactions. Early access to raltegravir was basically focused on patients on therapeutic failure and triple-class resistance and due to enfuvirtide intolerance. In order to achieve a better understanding of the efficacy and safety profile of raltegravir in the clinical setting, it is intended to evaluate retrospectively HIV patients treated in Portugal with raltegravir since the Early Access and Compassionate Use Program (EAP) was implemented.

This is a national, multicenter, observational, clinical cohort study with retrospective collection of data. Each site will include patients who had started treatment with raltegravir under the EAP.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

HIV-infected adult portuguese patients who started treatment with raltegravir since the Early Access Program and Compassionate Use Program (from March 2007 to December 2008)

HIV Infections
Not Provided
CohortHIV
Adult multiple-experienced HIV infected patients who needed to change their antiretroviral therapy and initiated raltegravir + optimized background therapy under the Early Access Program.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patients, aged 18 years or older
  2. ARV multi-experienced patients (i.e. experienced at least two prior regimens) with need to change current ARV therapy, including:

    • HIV-1 infected patients with documented therapeutic failure,
    • HIV-2 infected patients with documented therapeutic failure
    • HIV infected patients in virologic suppression who needed to change ARV due to inacceptable toxicity, as determined by the investigator, including patients who needed to replace T20
  3. Raltegravir-naïve patients who initiated raltegravir since the EAP Program, with optimized background therapy(OBT)
  4. Patient who has been followed at the same clinical site since the start of raltegravir

Exclusion Criteria:

  1. Acute or decompensated chronic hepatitis. Patients with serum aminotransferase levels 10 times the upper limit of the normal range or higher (grade 4)
  2. Patients who presented resistance to drugs included in OBT (namely, etravirine, darunavir or maraviroc)
  3. Non-existing medical records for viral load and TCD4 at baseline, week 24 and 48
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01190124
CohortHIV2008PT
No
Maria Manuela Doroana, MD, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
Doroana, Maria Manuela, M.D.
  • Merck Sharp & Dohme Corp.
  • Eurotrials, Scientific Consultants
Principal Investigator: Manuela S Doroana, MD Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
Doroana, Maria Manuela, M.D.
April 2011

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