Effects of Intensive cART During Acute/Early HIV Infection

NCT01154673 | Completed Phase 2 Results DMC

• 1 other identifier: 041009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.

Conditions

Acute HIV Infection

Outcome Measures

Primary Outcomes (1)

• Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.

  The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen.

  Baseline to Week 48

Study Arms (2)

Intensive HAART

EXPERIMENTAL

Patients in this arm will receive the following HAART regimen: Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID for 96 weeks

Drug: raltegravir; Drug: maraviroc; Drug: emtricitabine 200mg /tenofovir 300mg; Drug: lopinavir 400 mg/ritonavir 100mg

Placebo Arm

PLACEBO COMPARATOR

Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) for 48 weeks and then offered open label Raltegravir and Maraviroc after 48 weeks

Drug: emtricitabine 200mg /tenofovir 300mg; Drug: lopinavir 400 mg/ritonavir 100mg

Interventions

raltegravir DRUG

Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART

Also known as: Isentress, MK-0518

Intensive HAART

maraviroc DRUG

Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART

Also known as: Celsentri, Selzentry

Intensive HAART

emtricitabine 200mg /tenofovir 300mg DRUG

emtricitabine 200mg /tenofovir 300mg QD

Also known as: Truvada

Intensive HAART; Placebo Arm

lopinavir 400 mg/ritonavir 100mg DRUG

lopinavir 400 mg/ritonavir 100mg BID

Also known as: Kaletra, Aluvia

Intensive HAART; Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive HIV-1 antibody test result (Western blot), with a documented negative test result in the previous six months or
• Positive or weakly positive HIV-1 antibody screening ELISA test result, with indeterminate and evolving confirmatory test result with demonstrated HIV-1 antigenemia (p24 antigen test result) or viremia (HIV-1 bDNA ≥ 500 copies/ml) or
• Negative HIV-1 antibody test result in the setting of an illness compatible with acute seroconversion with demonstrated HIV-1 antigenemia (p24 antigen test result) or plasma viremia (HIV-1 bDNA ≥ 500 copies/ml)
• Ages 18 or older
• Ability to provide informed consent
• HIV-1 viral load ≥ 5,000 copies/ml

You may not qualify if:

• Participants who would have difficulty participating in a trial due to non-adherence or substance abuse
• Participants with any of the following abnormal laboratory test results in screening:
• Hemoglobin \< 85 g/L
• Neutrophil count \< 750 cells/uL
• Platelet count \< 50,000 cells/L
• AST or ALT \> 5X the upper limit of normal
• Creatinine \> 250 umol/L
• Participant with a malignancy
• Participant with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death
• Participant who is pregnant or who is trying to conceive

Sponsors & Collaborators

• University of Toronto: lead
• Unity Health Toronto: collaborator
• Maple Leaf Research: collaborator

Study Sites (2)

University of Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Maple Leaf Medical Clinic

Toronto, Ontario, M5G 1K2, Canada

Location

MeSH Terms

Interventions

Raltegravir Potassium; Maraviroc; Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir; Ritonavir; lopinavir-ritonavir drug combination

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Pyrimidinones; Thiazoles; Sulfur Compounds

Results Point of Contact

• Title: Mario Ostrowski, Principal Investigator, Professor of Medicine
• Organization: University of Toronto

mario.ostrowski@gmail.com

416-946-5805

Study Officials

• Mario Ostrowski, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Colin Kovacs, MD

  Maple Leaf Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: November 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 5, 2016
• Results First Posted: April 5, 2016

Record last verified: 2016-03

Locations

CA (2)