3TC or No 3TC for HIV With 3TC Resistance

NCT ID: NCT00143728

Last Updated: 2008-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the effects of continuing or discontinuing 3TC treatment in the presence of HIV virus with 3TC resistance for persons who are on a regimen including least three other anti-HIV drugs. The overall aim is to determine whether continuing 3TC is of benefit in HIV-positive persons who have already shown resistance to this drug.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV Treatment Experienced

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lamivudine

See Detailed Description.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be HIV positive
* Be at least 18 years old.
* Currently receiving 3TC for HIV infection in conjunction with at least three other antiretroviral drugs. Must have started this regimen at least three months prior to starting this study.
* A plasma viral load of less than 50 copies/mL on at least two occasions (measured at least 28 days apart immediately prior to screening).
* Evidence of resistance to 3TC

Exclusion Criteria

* Pregnancy or breastfeeding.
* Hepatitis B surface antigen (HbsAg) positive at time of screening or with the previous year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of British Columbia

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julio Montaner, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia/Providence Health Care

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Downtown IDC

Vancouver, British Columbia, Canada

Site Status

Cool Aid Community Health Centre

Victoria, British Columbia, Canada

Site Status

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Haven Program

Greater Sudbury, Ontario, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

Maple Leaf Clinic

Toronto, Ontario, Canada

Site Status

Sunnybrook Hospital

Toronto, Ontario, Canada

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Centre Hospitalier de l'université de Laval

Ste-Foy, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTN 189

Identifier Type: -

Identifier Source: secondary_id

P03-0051

Identifier Type: -

Identifier Source: org_study_id