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
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Condition or disease | Intervention/treatment | Phase |
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Acute HIV Infection | Drug: raltegravir Drug: maraviroc Drug: emtricitabine 200mg /tenofovir 300mg Drug: lopinavir 400 mg/ritonavir 100mg | Phase 2 Phase 3 |
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 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
Arm | Intervention/treatment |
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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:
Drug: maraviroc Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
Other Names:
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:
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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
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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:
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- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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:
- 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
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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

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 |
Principal Investigator: | Mario Ostrowski, MD | University of Toronto | |
Principal Investigator: | Colin Kovacs, MD | Maple Leaf Medical Clinic |
Responsible Party: | Mario Ostrowski, Principal Investigator, University of Toronto |
ClinicalTrials.gov Identifier: | NCT01154673 |
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 |
Infection 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 Ritonavir Lopinavir |
Tenofovir Emtricitabine Raltegravir Potassium Maraviroc 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 |