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Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 | Clinical Trials | Clareo Health

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Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1

Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile

NCT00993148•Northwestern University

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry
•Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtained within 90 days prior to study entry
•Exclusive R5 tropism based on enhanced sensitivity Trofile assay done within 90 days prior to entry
•CD4 cell count \> 100 cells/mm3 within 90 days prior to study entry
•HIV genotype (for RT and protease) performed at any time before study entry (Subjects with single or combination NNRTI or NRTI RAM(s) at screening are permitted)
•ARV drug-naïve, defined as no previous ARV treatment at any time prior to study entry
•Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
•Negative result from a hepatitis C antibody test performed within 90 days prior to study entry
•Laboratory values obtained within 30 days prior to study entry:
•* ANC \>=750/mm3
+8 more criteria

Exclusion Criteria

•Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry
•Screening HIV genotype obtained any time prior to study entry with any DRV RAM (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)
•Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy. NOTE: Subjects receiving stable physiologic glucocorticoid doses (defined as prednisone ≤10 mg/day \[or equivalent\] as a stable or tapering dose) are permitted. Subjects receiving corticosteroids for acute therapy for PCP or asthma exacerbation, or receiving a short course (defined as ≤2 weeks of pharmacologic glucocorticoid therapy) are permitted
•Breast-feeding
•Requirement for any medication that is prohibited with a study medication
•Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion
•Active drug or alcohol use or dependence that could interfere with adherence to study requirements

Locations (5)

Quest Clinical Research

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

CORECenter

Chicago, Illinois, United States

University of Nebraska

Omaha, Nebraska, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

September 5, 2014

Enrollment

ACTUAL participants

Conditions

HIV-1 InfectionHIV Infections

Interventions

maraviroc

DRUG

darunavir

DRUG

ritonavir

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1

Inclusion Criteria

Exclusion Criteria

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