Effects of Intensive cART During Acute/Early HIV Infection

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Toronto
• Collaborators: Maple Leaf Medical Clinic; St. Michael's Hospital, Toronto; Unity Health Toronto
• Treatments: Emtricitabine; Lopinavir; Maraviroc; Raltegravir Potassium; Ritonavir; Tenofovir

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:

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