Effects of Intensive cART During Acute/Early HIV Infection
Acute HIV Infection
About this trial
This is an interventional treatment trial for Acute HIV Infection
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
Sites / Locations
- University of Toronto
- Maple Leaf Medical Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intensive HAART
Placebo Arm
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