Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 (MIDAS)
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ClinicalTrials.gov Identifier: NCT00993148 |
Recruitment Status :
Completed
First Posted : October 12, 2009
Results First Posted : August 19, 2014
Last Update Posted : September 5, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-1 Infection HIV Infections | Drug: maraviroc Drug: darunavir Drug: ritonavir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Maraviroc plus darunavir/ritonavir
Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
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Drug: maraviroc
150 mg tab by mouth once daily for 96 weeks
Other Name: Selzentry Drug: darunavir 800 mg tab by mouth once daily for 96 weeks
Other Name: Prezista Drug: ritonavir 100 mg capsule by mouth once daily for 96 weeks
Other Name: norvir |
- Percentage of Participants With Plasma HIV-1 RNA >50 [ Time Frame: 24 weeks ]Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL
- Percentage of Participants With Virologic Failure or Off Study Treatment Regimen [ Time Frame: 24 weeks ]Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)
- Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL [ Time Frame: 48 weeks ]Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
- Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher [ Time Frame: 96 weeks ]Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen
- Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES [ Time Frame: At study entry and at the time of virologic failure ]
- Drug Adherence, Number of Participants With Missed Doses [ Time Frame: Week 24 ]Drug adherence, assessed as number of participants with missed doses over four-day recall
- Trough Concentrations (Ctrough) of Maraviroc [ Time Frame: 24 hours ]Average trough concentration (Ctrough) of maraviroc
- Median CD4 Count Change From Baseline [ Time Frame: 96 weeks ]Median changes from baseline in peripheral CD4+ T-cell count
- Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL [ Time Frame: 96 weeks ]Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Laboratory values obtained within 30 days prior to study entry:
- ANC >=750/mm3
- Hemoglobin >=10 g/dL
- Platelets >=50,000/mm3
- AST (SGOT), ALT (SGPT), and alkaline phosphatase <=5 x ULN
- Calculated creatinine clearance (CrCl) >=30 mL/min, as estimated by the Cockcroft-Gault equation*
- Negative serum or urine pregnancy test within 48 hours prior to study entry for women with reproductive potential
- If participating in sexual activity that could lead to pregnancy, the study subjects with reproductive potential must use one form of contraceptive while receiving protocol-specified medications and for 60 days after stopping the medications.
- Men and women age >=18 years
- Ability and willingness of subject or legal guardian/representative to provide informed consent
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993148
United States, California | |
Quest Clinical Research | |
San Francisco, California, United States | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
CORECenter | |
Chicago, Illinois, United States, 60612 | |
United States, Nebraska | |
University of Nebraska | |
Omaha, Nebraska, United States |
Principal Investigator: | Babafemi Taiwo, MD | Northwestern University |
Responsible Party: | Babafemi Taiwo, Associate Professor, Northwestern University |
ClinicalTrials.gov Identifier: | NCT00993148 |
Other Study ID Numbers: |
MIDAS |
First Posted: | October 12, 2009 Key Record Dates |
Results First Posted: | August 19, 2014 |
Last Update Posted: | September 5, 2014 |
Last Verified: | August 2014 |
Treatment naive |
Infection Communicable Diseases Ritonavir Darunavir Maraviroc HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors HIV Fusion Inhibitors Viral Fusion Protein Inhibitors CCR5 Receptor Antagonists |