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

Northwestern University

Status and phase

Completed

Phase 2

Conditions

HIV-1 Infection

HIV Infections

Treatments

Drug: maraviroc

Drug: darunavir

Drug: ritonavir

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00993148

MIDAS

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
- 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