NCT00200369

Brief Summary

The hypothesis of this study is that the level of adherence necessary to achieve HIV virologic suppression with a ritonavir boosted protease inhibitor regimen (i.e. lopinavir/ritonavir) is less than the 95% rate observed in the published literature with unboosted regimens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 5, 2009

Status Verified

November 1, 2009

First QC Date

September 12, 2005

Last Update Submit

November 4, 2009

Conditions

HIV Infection

Keywords

HIVAdherenceAntiretroviral therapyProtease inhibitorLopinavir

Interventions

MEMS capDEVICE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic with eligibility criteria as listed below.

You may qualify if:

  • HIV infection
  • Receiving twice daily Kaletra at an FDA approved dosage
  • Age\>18 years
  • CD4 and viral load available within seven day of enrollment
  • Patient willingness to accept MEMS cap monitoring
  • HIV genotype within 60 days of enrollment for patients with viral load\>1000
  • Patient willingness to grant informed consent and complete five study visits

You may not qualify if:

  • Provider or patient deem it unlikely that Kaletra therapy will continue for the ensuing 24 weeks
  • Prescription of any medication that is contraindicated for Kaletra recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center I.D. Clinic

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • Shuter J, Sarlo JA, Kanmaz TJ, Rode RA, Zingman BS. HIV-infected patients receiving lopinavir/ritonavir-based antiretroviral therapy achieve high rates of virologic suppression despite adherence rates less than 95%. J Acquir Immune Defic Syndr. 2007 May 1;45(1):4-8. doi: 10.1097/QAI.0b013e318050d8c2.

    PMID: 17460469DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jonathan Shuter, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2004

Study Completion

March 1, 2006

Last Updated

November 5, 2009

Record last verified: 2009-11

Locations

US(1)