NCT00285883

CompletedPhase 3

Directly Observed Therapy in High Risk Populations in Newark...

Saint Michael's Medical Center Source

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Other study identifiers

Sponsor study identifier

36/03

Study Type

interventional

Reported enrollment (type unavailable)

30

Locations

1 country

Sites

1

Timeline

Study Start

April 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

May 2006

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 30 participants
Study completion date: May 2006
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 31, 2006
Actual (reported)
First Posted
February 2, 2006
Actual (reported)
Study Completion
May 2006
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: February 28, 2006
Status Verified: January 2006
Last Update Submitted: February 27, 2006

Conditions

Directly Observed Therapy HIV 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:

Sponsors & Collaborators

Hoffmann-La Roche
Industrycollaborator
Saint Michael's Medical Center
Otherlead

Study Sites (1)

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

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, Viral

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 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

May 2006

Date type not reported

This date has not been verified as actual or estimated.

Phase 3Completed

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Phase 3Terminated

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Phase 3Completed

NCT00009061

Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

Phase 3Unknown

NCT00421551

Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136

Phase 3Completed

NCT00105079

GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

Phase 3Completed

NCT00135343

A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

Phase 3Completed

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

Contact the study team to confirm eligibility.

Sexually Transmitted Diseases

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Virus Diseases

Genital Diseases

Urogenital Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Last Updated

February 28, 2006

Record last verified: 2006-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00285883
Data provider: ClinicalTrials.gov
Source updated: 2006-02-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:03 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations