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Effects of Intensive cART During Acute/Early HIV Infection

Primary Purpose

Acute HIV Infection

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

raltegravir

maraviroc

emtricitabine 200mg /tenofovir 300mg

lopinavir 400 mg/ritonavir 100mg

About this trial

This is an interventional treatment trial for Acute HIV Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The major single criterion for inclusion into the study will be the presence of confirmed acute/early HIV-1 infection, as defined by one of the three following criteria:

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)

Other inclusion criteria are:

Ages 18 or older
Ability to provide informed consent
HIV-1 viral load ≥ 5,000 copies/ml

Exclusion Criteria:

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

Sites / Locations

University of Toronto
Maple Leaf Medical Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intensive HAART

Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01154673

First Posted

June 29, 2010

Last Updated

March 4, 2016

Sponsor

University of Toronto

Collaborators

Unity Health Toronto, Maple Leaf Research

1. Study Identification

Unique Protocol Identification Number

NCT01154673

Brief Title

Effects of Intensive cART During Acute/Early HIV Infection

Official Title

Randomized, Double-blinded, Controlled Trial of Intensive HAART Including Raltegravir, and Maraviroc, on HIV-1 Pro-viral DNA and Reservoir Decay in HIV-1-infected Individuals During the Acute/Early Infection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

Collaborators

Unity Health Toronto, Maple Leaf Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The trial is a prospective, randomized, double-blinded, placebo-controlled study with follow-up to 5 years. Thirty-two individuals presenting with newly diagnosed acute or early HIV-1 infection as described in the inclusion criteria will be enrolled, with sixteen randomized to each arm. Individuals will be randomized to one of two arms: the "Intensive" arm with standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400mg /ritonavir 100mg BID) + Raltegravir + Maraviroc or the "placebo" arm with standard HAART+ Placebo for 48 weeks. Another group of individuals diagnosed with acute or early HIV-1 who elect to forego early treatment will be followed as non-randomized, untreated controls. At week 48, all patients will be informed of study results. If results are positive in the intensive treatment group, the placebo group will be offered to roll-over to the intense treatment arm and followed as an open-label cohort out to five years. Participants may stop treatment at any time and withdraw from the study. If they choose to do so, they will be followed according to the standards employed for all HIV-1 patients at the Maple Leaf clinic. At the five year point, the decision to terminate treatment will be made based on the existing state of the HIV-1 literature at the time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute HIV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive HAART

Arm Type

Experimental

Arm Description

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

raltegravir

Other Intervention Name(s)

Isentress, MK-0518

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

maraviroc

Other Intervention Name(s)

Celsentri, Selzentry

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

emtricitabine 200mg /tenofovir 300mg

Other Intervention Name(s)

Truvada

Intervention Description

emtricitabine 200mg /tenofovir 300mg QD

Intervention Type

Drug

Intervention Name(s)

lopinavir 400 mg/ritonavir 100mg

Other Intervention Name(s)

Kaletra, Aluvia

Intervention Description

lopinavir 400 mg/ritonavir 100mg BID

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline to Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The major single criterion for inclusion into the study will be the presence of confirmed acute/early HIV-1 infection, as defined by one of the three following criteria: 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) Other inclusion criteria are: Ages 18 or older Ability to provide informed consent HIV-1 viral load ≥ 5,000 copies/ml Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario Ostrowski, MD

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Colin Kovacs, MD

Organizational Affiliation

Maple Leaf Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Maple Leaf Medical Clinic

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1K2

Country

Canada

12. IPD Sharing Statement

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Effects of Intensive cART During Acute/Early HIV Infection

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