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

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ClinicalTrials.gov Identifier: NCT01190124
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : May 19, 2011
Last Update Posted : May 19, 2011
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Eurotrials Brasil Consultores Cientificos Ltda
Information provided by:
Doroana, Maria Manuela, M.D.

Brief Summary:

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.

Condition or disease
HIV Infections

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : April 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. HIV-RNA Levels [ Time Frame: Baseline ]
    Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.

  2. HIV-RNA Levels [ Time Frame: week 24 ]
    Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.

  3. HIV-RNA Levels [ Time Frame: week 48 ]
    Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.

  4. CD4 Cells Count [ Time Frame: Baseline ]
    CD4 cells count at baseline.

  5. CD4 Cells Count [ Time Frame: week 24 ]
    CD4 cells count at week 24.

  6. CD4 Cells Count [ Time Frame: week 48 ]
    CD4 cells count at week 48.


Secondary Outcome Measures :
  1. HIV-RNA Levels [ Time Frame: Baseline ]
    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.

  2. HIV-RNA Levels [ Time Frame: Week 24 ]
    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.

  3. HIV-RNA Levels [ Time Frame: Week 48 ]
    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.

  4. CD4 Cells Count [ Time Frame: Baseline ]
    For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.

  5. CD4 Cells Count [ Time Frame: Week 24 ]
    For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.

  6. CD4 Cells Count [ Time Frame: Week 48 ]
    For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.

  7. CD4 Cells Count [ Time Frame: Baseline ]
    For the HIV-2 infected patients CD4 cells count will be assessed at baseline.

  8. CD4 Cells Count [ Time Frame: Week 24 ]
    For the HIV-2 infected patients CD4 cells count will be assessed at week 24.

  9. CD4 Cells Count [ Time Frame: Week 48 ]
    For the HIV-2 infected patients CD4 cells count will be assessed at week 48.

  10. HIV-RNA Levels [ Time Frame: Baseline ]
    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.

  11. HIV-RNA Levels [ Time Frame: Week 24 ]
    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.

  12. HIV-RNA Levels [ Time Frame: Week 48 ]
    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.

  13. Adverse Drug Reactions [ Time Frame: Week 48 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190124


Sponsors and Collaborators
Doroana, Maria Manuela, M.D.
Merck Sharp & Dohme Corp.
Eurotrials Brasil Consultores Cientificos Ltda
Investigators
Principal Investigator: Manuela S Doroana, MD Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

Responsible Party: Maria Manuela Doroana, MD, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
ClinicalTrials.gov Identifier: NCT01190124     History of Changes
Other Study ID Numbers: CohortHIV2008PT
First Posted: August 27, 2010    Key Record Dates
Results First Posted: May 19, 2011
Last Update Posted: May 19, 2011
Last Verified: April 2011

Keywords provided by Doroana, Maria Manuela, M.D.:
HIV infections
HIV-1
HIV-2
Acquired Immunodeficiency Syndrome
AIDS
Anti-Retroviral Agents
Raltegravir
Integrase Inhibitors
multiple-experienced HIV infected patients

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action