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HIV InfectionsNCT01190124

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

An observational study of HIV Infections, run by Doroana, Maria Manuela, M.D..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
How many people
151 participants
Where
No sites listed yet
Study dates
Apr 2010to Jul 2010
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • Male or female patients, aged 18 years or older
  • 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
  • Raltegravir-naïve patients who initiated raltegravir since the EAP Program, with optimized background therapy(OBT)
  • Patient who has been followed at the same clinical site since the start of raltegravir

Who cannot join

  • Acute or decompensated chronic hepatitis. Patients with serum aminotransferase levels 10 times the upper limit of the normal range or higher (grade 4)
  • Patients who presented resistance to drugs included in OBT (namely, etravirine, darunavir or maraviroc)
  • Non-existing medical records for viral load and TCD4 at baseline, week 24 and 48

About this study

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

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:

Read more
  • 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.
Read the 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.

Conditions
HIV Infections
Keywords
HIV infections, HIV-1, HIV-2, Acquired Immunodeficiency Syndrome, AIDS, Anti-Retroviral Agents, Raltegravir, Integrase Inhibitors, multiple-experienced HIV infected patients
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01190124
Study groupRoleWhat they receive
CohortHIVAdult multiple-experienced HIV infected patients who needed to change their antiretroviral therapy and initiated raltegravir + optimized background therapy under the Early Access Program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV-RNA Levels

    Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.

    Measured: Baseline

  2. HIV-RNA Levels

    Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.

    Measured: week 24

  3. HIV-RNA Levels

    Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.

    Measured: week 48

  4. CD4 Cells Count

    CD4 cells count at baseline.

    Measured: Baseline

  5. CD4 Cells Count

    CD4 cells count at week 24.

    Measured: week 24

  6. CD4 Cells Count

    CD4 cells count at week 48.

    Measured: week 48

Secondary outcomes (13)

  1. HIV-RNA Levels

    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.

    Measured: Baseline

  2. HIV-RNA Levels

    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.

    Measured: Week 24

  3. HIV-RNA Levels

    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.

    Measured: Week 48

  4. CD4 Cells Count

    For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.

    Measured: Baseline

  5. CD4 Cells Count

    For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.

    Measured: Week 24

  6. CD4 Cells Count

    For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.

    Measured: Week 48

  7. CD4 Cells Count

    For the HIV-2 infected patients CD4 cells count will be assessed at baseline.

    Measured: Baseline

  8. CD4 Cells Count

    For the HIV-2 infected patients CD4 cells count will be assessed at week 24.

    Measured: Week 24

  9. CD4 Cells Count

    For the HIV-2 infected patients CD4 cells count will be assessed at week 48.

    Measured: Week 48

  10. HIV-RNA Levels

    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.

    Measured: Baseline

  11. HIV-RNA Levels

    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.

    Measured: Week 24

  12. HIV-RNA Levels

    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.

    Measured: Week 48

  13. Adverse Drug Reactions

    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.

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01190124
Sponsor's protocol ID
CohortHIV2008PT
Status last verified
Apr 2011
First submitted
25 Aug 2010
Last updated
19 May 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Doroana, Maria Manuela, M.D..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-RNA Levels (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01190124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.

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