Status:
COMPLETED
Effects of Intensive cART During Acute/Early HIV Infection
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Unity Health Toronto
Maple Leaf Research
Conditions:
Acute HIV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 o...
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 des...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01154673
Start Date
November 1 2011
End Date
September 1 2014
Last Update
April 5 2016
Active Locations (2)
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1
University of Toronto
Toronto, Ontario, Canada, M5B 1W8
2
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5G 1K2