Phase 3 N=32 Randomized Quadruple-blind Treatment

Effects of Intensive cART During Acute/Early HIV Infection

Acute HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT01154673 ↗

Enrolled (actual)

Serious AEs

3.1%

Results posted

Apr 2016

Primary outcome: Primary: 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. — 279; 244 HIV DNA copies/ million CD4 cells — p=0.056

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: raltegravir (Drug); maraviroc (Drug); emtricitabine 200mg /tenofovir 300mg (Drug); lopinavir 400 mg/ritonavir 100mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Toronto
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	279; 244	0.056

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01154673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.