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Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.

NCT01258374 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2019-09-27

Study results available
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Summary

While 3-drug regimens remain standard of care, concerns exist regarding the safety of multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted successful trials with ritonavir (RTV) boosted PI monotherapy, however long term safety and efficacy of such regimens remains unknown. Clinical trials have shown Raltegravir (RAL) to have potent activity when patients have few active background drugs; it has a superior lipid profile compared with EFV and LPV/RTV. Darunavir/r (DRV) is a potent, well tolerated PI with few GI side effects and lipid disturbances and with a high genetic barrier. The investigators hypothesized that RAL/DRV would be a well tolerated and effective regimen for those patients who are failing nucleoside reverse transcriptase inhibitors based regimens, due to poor tolerability or resistance. The investigators also would like to explore the plasma pharmacokinetics of Raltegravir combined with Darunavir in a sub-group of 12 HIV-infected patients.

Conditions

  • Integrase Inhibitors, HIV; HIV PROTEASE INHIB

Interventions

DRUG

Raltegravir

Raltegravir, 400 mg bid

DRUG

Darunavir

Darunavir, 800 mg QD + ritonavir 100 mg QD

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Josep Mallolas, MD, PhD · Hospital Clinic of Barcelona

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-05-31
Completion
2011-12-31

Countries

  • Spain

Study Locations

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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 NCT01258374 on ClinicalTrials.gov