NCT00874523

Brief Summary

To compare the steady-state pharmacokinetics and short-term efficacy and safety of two dosing strategies of raltegravir and atazanavir in virologically suppressed HIV-infected adults receiving atazanavir-containing combination antiretroviral therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2010

Enrollment Period

2 years

First QC Date

March 31, 2009

Last Update Submit

April 10, 2012

Conditions

HIV Infection

Keywords

raltegraviratazanavirHIV infectionspharmacokineticsantiretroviral agentstreatment experienced

Outcome Measures

Primary Outcomes (1)

  • comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies

    4 and 8 weeks

Secondary Outcomes (8)

  • comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing

    4 and 8 weeks

  • comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir

    4 and 8 weeks

  • comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir

    4 and 8 weeks

  • change from baseline in fasting lipid and glycaemic parameters

    weeks 4 and 8 and overall

  • change from baseline in CD4+ T-lymphocyte count

    weeks 4 and 8 and overall

  • +3 more secondary outcomes

Study Arms (2)

Arm A

ACTIVE COMPARATOR
Drug: atazanavir plus raltegravir

Arm B

ACTIVE COMPARATOR
Drug: atazanavir plus raltegravir

Interventions

atazanavir plus raltegravirDRUG

atazanavir 300 mg + raltegravir 400 mg twice daily for 4 weeks then atazanavir 300 mg + ritonavir 100 mg + raltegravir 800 mg once daily for 4 weeks

Also known as: Reyataz, Isentress
Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged ≥ 18 years with laboratory evidence of HIV-1 infection
  • currently receiving 3 or more unchanged antiretroviral agents including atazanavir (with or without ritonavir boosting) for at least 24 weeks prior to study entry
  • plasma HIV RNA less than 50 copies/mL for at least 24 weeks prior to study entry
  • provide written, informed consent.

You may not qualify if:

  • prior clinical/virological failure on a PI-containing regimen
  • no clinical history of primary HIV-1 protease mutations identified in local baseline genotypic analysis of HIV with interpretation using current IAS-USA Drug Resistance Mutations in HIV-1
  • women: pregnant, breastfeeding, or not willing to use adequate contraception (including barrier contraception) if of child-bearing potential
  • laboratory abnormalities at screening:
  • absolute neutrophil count (ANC) \< 750 cells/mL
  • haemoglobin less than 8.5 g/dL
  • platelet count less than 50 000 cells/mL
  • AST, ALT \> 5 times the upper limit of normal
  • serum bilirubin \> 5 times the upper limit of normal
  • chronic active hepatitis B infection defined by presence of serum viral hepatitis B surface antigen (HBsAg) or HBV DNA-positive
  • any malabsorption syndrome likely to affect drug absorption
  • concurrent therapy with human growth hormone or other immunomodulatory agents
  • concomitant medication contraindicated for use with either atazanavir or raltegravir therapy
  • any inter-current illness requiring hospitalisation
  • current excessive alcohol or illicit substance use
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir SulfateRaltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsPyrrolidinonesPyrrolidines

Study Officials

  • David A Cooper, MD DSc

    Kirby Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 12, 2012

Record last verified: 2010-04

Locations

AU(2)