NCT00207168

CompletedPhase 4

To Assess Compliance With a Once-daily Regimen of Lamivudine...

Bristol-Myers Squibb Source

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Other study identifiers

Sponsor study identifier

AI454-194

Secondary identifiers

The TEddI Study

Study Type

interventional

Reported enrollment (type unavailable)

120

Locations

0 countries

Sites

N/A

Timeline

Study Start

April 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2006

Actual (reported)

Study Completion

December 2006

Actual (reported)

Brief Summary

To assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.

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): 120 participants
Study completion date: December 2006
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

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
September 12, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Primary Completion
December 2006
Actual (reported)
Study Completion
December 2006
Actual (reported)

Last Updated: April 22, 2011
Status Verified: April 2011
Last Update Submitted: April 8, 2011

Conditions

AIDS

Outcome Measures

Primary Outcomes (1)

To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomized to receive either a once daily 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.

Secondary Outcomes (1)

To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure.

Interventions

ComplianceBehavioral

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential.

You may not qualify if:

Sponsors & Collaborators

Dohme Australia
Type not reportedcollaborator
Merck Sharp & Dohme LLC
Industrycollaborator
Bristol-Myers Squibb

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Compliance

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital Diseases

Study Officials

Bristol-Myers Squibb
Bristol-Myers Squibb
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

April 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2006

Actual (reported)

NCT00775606

Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease

Phase 4Terminated

NCT00853840

Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Phase 4Completed

NCT00116116

DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy

Phase 4Completed

NCT00214435

Once Daily 3TC, Efavirenz and ddI for HIV Infection

Phase 4Unknown

NCT02191215

Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

Completed

NCT00272220

Longitudinal Study of HAART, Social Networks, & Adherence

Not ApplicableCompleted

virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding

Contact the study team to confirm eligibility.

Industrylead

Urogenital Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Intervention Hierarchy (Ancestors)

ElasticityMechanical PhenomenaPhysical Phenomena

Study Completion

December 2006

Actual (reported)

Last Updated

April 22, 2011

Record last verified: 2011-04

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: NCT00207168
Data provider: ClinicalTrials.gov
Source updated: 2011-04-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:19 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record