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

NCT01190124 | Completed Results

• 1 other identifier: CohortHIV2008PT
• Study Type: observational
• Target: 151
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (6)

• HIV-RNA Levels

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

  Baseline

• HIV-RNA Levels

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

  week 24

• HIV-RNA Levels

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

  week 48

• CD4 Cells Count

  CD4 cells count at baseline.

  Baseline

• CD4 Cells Count

  CD4 cells count at week 24.

  week 24

• CD4 Cells Count

  CD4 cells count at week 48.

  week 48

Secondary Outcomes (13)

• HIV-RNA Levels

  Baseline

• HIV-RNA Levels

  Week 24

• HIV-RNA Levels

  Week 48

• CD4 Cells Count

  Baseline

• CD4 Cells Count

  Week 24

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Doroana, Maria Manuela, M.D.: lead
• Merck Sharp & Dohme LLC: collaborator
• Eurotrials Brasil Consultores Cientificos Ltda: collaborator

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Results Point of Contact

• Title: Doroana, Maria Manuela, M.D.
• Organization: Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

manuela.doroana@hsm.min-saude.pt

351 217938043

Study Officials

• Manuela S Doroana, MD

  Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 19, 2011
• Results First Posted: May 19, 2011

Record last verified: 2011-04