NCT00285883

Brief Summary

30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center and be given Directly observed therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 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

April 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 28, 2006

Status Verified

January 1, 2006

First QC Date

January 31, 2006

Last Update Submit

February 27, 2006

Conditions

Directly Observed TherapyHIV Infections

Keywords

InviraseHIVDOTTreatment Experienced

Interventions

InviraseDRUG
NorvirDRUG

Eligibility Criteria

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

You may qualify if:

  • \. Men and Women \> 18 years of age with a confirmed HIV-1 diagnosis 2. CD4 count \<350 and or history of opportunistic infection 3. HIV PCR \>55000 and \>55,000 on one occasion in last 12 months 4. Patients with poor compliance (Poor compliance will de defined as taking less than 80 percent of prescribed medication 5. Patients with mental illness, HIV dementia, substance abuse or social factor prohibiting compliance 6. Willingness to sign informed consent or legal guardian

You may not qualify if:

  • ALT/AST \> 5X ULN
  • CReatinine \>2.0 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Directly Observed TherapyHIV Infections

Interventions

SaquinavirRitonavir

Condition Hierarchy (Ancestors)

Medication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolinesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jihad Slim, MD

    Saint Michael's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 2, 2006

Study Start

April 1, 2004

Study Completion

May 1, 2006

Last Updated

February 28, 2006

Record last verified: 2006-01

Locations

US(1)