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

NCT01190124 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 151

Last updated 2011-05-19

Study results available
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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.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Eurotrials Brasil Consultores Cientificos Ltda

    collaborator INDUSTRY

  • Doroana, Maria Manuela, M.D.

    lead INDIV

Principal Investigators

  • Manuela S Doroana, MD · Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190124 on ClinicalTrials.gov