NCT01013987

Brief Summary

Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects. The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
Last Updated

February 10, 2010

Status Verified

November 1, 2009

First QC Date

November 13, 2009

Last Update Submit

February 9, 2010

Conditions

HIV-1 Adults PatientsAIDSTriple Class Failure

Keywords

HIV-1triple class failureMaravirocRaltegravirDarunavir/ritonavirMaraviroc with raltegravir and darunavir/ritonavir

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24

    week 24

Secondary Outcomes (1)

  • Proportion of patients with HIV RNA levels of less than 50 copies/ml at week 24 and with HIV RNA levels of less than 400 copies/ ml at weeks 24 and 48.

    week 24 and week 48

Interventions

maravirocDRUG

maraviroc: one 150 mg pill twice daily

Also known as: Celsentri
RaltegravirDRUG

raltegravir : one 400 mg pill twice daily

Also known as: Issentres
Darunavir/ritonavirDRUG

* darunavir : two 300 mg pills twice daily with meal * ritonavir: one 100 mg pill twice daily with meal

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subject is at least 21 years of age.
  • Patient with documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or alternatively, a plasma HIV- RNA ≥10,000 copies/ml ever documented.
  • Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
  • Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the approval of the trial physician.
  • Documented HIV RNA \>500 copies/ml
  • Subject triple class antiretroviral failure (NRTI, NNRTI, PI)
  • Subject naïve to CCR5-inhibitors, integrase-inhibitors and darunavir.
  • Subjects can comply with protocol requirements.
  • Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial.
  • If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must:
  • use of a double birth control method that includes at least one barrier method, that is acceptable to both the subject and investigator, and
  • has a urine pregnancy test performed at the Screening Visit and on Baseline, and results of both tests must be negative.
  • continue practicing birth control methods for at least 30 days after the end of the treatment period.
  • Subject present R5 HIV1 at Screening, verified by Trofile Essay by Monogram Bioscience.

You may not qualify if:

  • Evidence of resistance against Maraviroc, Raltegravir, Darunavir/Ritonavir, based on the resistance test performed at Screening.
  • Previously documented HIV-2 infection.
  • Use of disallowed concomitant therapy listed in guidelines for use of each drug.
  • Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>5 x upper limit of normal (ULN) AND/OR is likely to require treatment in the next year.
  • Any active clinically significant disease (e.g. tuberculosis, cardiac disfunction, pancreatitis) or findings during screening of medical history or physical examination that, in the investigator´s opinion, would compromise the subject´s safety or outcome of the trial or adherence to the trial protocol.
  • Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV infection 1993) within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled.
  • Life expectancy \< 1 year according to the judgment of the investigator.
  • Screening laboratory analysis show any of the following abnormal laboratory results:
  • Hemoglobin \< 8.0 g/dL
  • Absolute neutrophil count \< 750 cells/µL
  • Platelet count \< 50,000 mm3
  • Subject enrolled in other clinical trials that include any blood sampling, specimen collection, or other interventional procedure. Concurrent participation in non-interventional observational trials
  • Use of any investigational agents within 30 days prior to screening.
  • Use of immunosuppressive drugs, cytokine inhibitors or other cytokines in the last year.
  • Any condition (including but not limited to alcohol and drug use) which in the opinion of the investigator, could compromise the subject's safety or adherence to the protocol;.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Huésped

Ciudad de Buenos Aires, C1202ABB, Argentina

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

MaravirocRaltegravir PotassiumDarunavirRitonavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolidinonesPyrrolidinesSulfonamidesAmidesCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransThiazoles

Central Study Contacts

Alejandro Krolewiecki, MD

CONTACT

54-11-4981-7777alekrol@huesped.org.ar

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

February 1, 2010

Last Updated

February 10, 2010

Record last verified: 2009-11

Locations

AR(1)