BRAVO: Background Regimen of Raltegravir on Virologic Outcome

Community Research Initiative of New England

Status: Completed

Conditions: HIV Infections

Treatments: Drug: raltegravir

Study type: Observational

Funder types: Other

Identifiers

NCT00751530

07-11

Details and patient eligibility

About

This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.

Full description

EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as GSS and PSS.

Enrollment: 442 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients previously enrolled in the MK 0518 EAP are eligible

• Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:

  • Age >= 16 years
  • Limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens, documented resistance to at least one drug in each of the 3 classes of oral ARTs (NRTI, NNRTI, PI) by genotype or phenotype testing, intolerance defined as having had a clinically significant adverse event which in the opinion of the clinician provides a contraindication to the use of any drug in that class iii. Patient did not achieve virologic suppression on ART regimen prior to receipt of raltegravir iv. Patient was clinically stable at time of initiation of raltegravir, eg. clinical status and all chronic medications (except ARTs) unchanged for >= 2 weeks prior to raltegravir receipt.

• Patient received raltegravir for at least 8 weeks

• Baseline and week 8 or later HIV viral load done and available for review

• Resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir

Exclusion criteria

• Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.
• Patient chart not available for review.

Trial design

442 participants in 2 patient groups

Protease Inhibitor Group

Description:

Subjects who required a protease inhibitor in their new ART regimen

Treatment:

Drug: raltegravir

Non-protease Inhibitor

Description:

Subjects who did not take a protease inhibitor in their regimen

Treatment:

Drug: raltegravir