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Effects of Intensive cART During Acute/Early HIV Infection

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ClinicalTrials.gov Identifier: NCT01154673
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Acute HIV Infection Drug: raltegravir Drug: maraviroc Drug: emtricitabine 200mg /tenofovir 300mg Drug: lopinavir 400 mg/ritonavir 100mg Phase 2 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2011
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intensive HAART

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
Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
Other Names:
  • Isentress
  • MK-0518
Drug: maraviroc
Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
Other Names:
  • Celsentri
  • Selzentry
Drug: emtricitabine 200mg /tenofovir 300mg
emtricitabine 200mg /tenofovir 300mg QD
Other Name: Truvada
Drug: lopinavir 400 mg/ritonavir 100mg
lopinavir 400 mg/ritonavir 100mg BID
Other Names:
  • Kaletra
  • Aluvia
Placebo Comparator: Placebo Arm
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
emtricitabine 200mg /tenofovir 300mg QD
Other Name: Truvada
Drug: lopinavir 400 mg/ritonavir 100mg
lopinavir 400 mg/ritonavir 100mg BID
Other Names:
  • Kaletra
  • Aluvia

Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: Baseline to Week 48 ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Positive HIV-1 antibody test result (Western blot), with a documented negative test result in the previous six months or
  2. 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
  3. 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:

  1. Participants who would have difficulty participating in a trial due to non-adherence or substance abuse
  2. 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
  3. Participant with a malignancy
  4. Participant with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death
  5. Participant who is pregnant or who is trying to conceive
Contacts and Locations

Information from the National Library of Medicine

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): NCT01154673

Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5B 1W8
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5G 1K2
Sponsors and Collaborators
University of Toronto
St. Michael's Hospital, Toronto
Maple Leaf Medical Clinic
Principal Investigator: Mario Ostrowski, MD University of Toronto
Principal Investigator: Colin Kovacs, MD Maple Leaf Medical Clinic
More Information

Responsible Party: Mario Ostrowski, Principal Investigator, University of Toronto
ClinicalTrials.gov Identifier: NCT01154673     History of Changes
Obsolete Identifiers: NCT01101516
Other Study ID Numbers: 041009
First Posted: July 1, 2010    Key Record Dates
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Raltegravir Potassium
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
Reverse Transcriptase Inhibitors