NCT01154673

Effects of Intensive cART During Acute/Early HIV Infection

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute HIV Infection

Interventions

Type	Name	Description
DRUG	raltegravir	Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
DRUG	maraviroc	Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
DRUG	emtricitabine 200mg /tenofovir 300mg	emtricitabine 200mg /tenofovir 300mg QD
DRUG	lopinavir 400 mg/ritonavir 100mg	lopinavir 400 mg/ritonavir 100mg BID

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2010-07-01
• Last updated: 2016-04-05
• Results posted: 2016-04-05

Locations

2 sites across 1 country: Canada