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

Phase 4

Suspended

• Conditions: HIV Infections

• Registration Number: NCT00143728
• Lead Sponsor: University of British Columbia

Brief Summary

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

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-24
• Last Update Posted: 2008-09-25
• Primary Completion: 2010-05
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Virologic failure (VL above 50 copies/ml) on two consecutive dates, at least two weeks apart, in the absence of concurrent acute illness or recent immunization during the first 24 weeks.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Percent and absolute change in viral load from baseline to week 24 and week 48.	48 weeks
Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.	48 weeks

Trial Locations

Locations (9)

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Sunnybrook Hospital; 🇨🇦 Toronto, Ontario, Canada

Downtown IDC; 🇨🇦 Vancouver, British Columbia, Canada

Haven Program; 🇨🇦 Sudbury, Ontario, Canada

Maple Leaf Clinic; 🇨🇦 Toronto, Ontario, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier de l'université de Laval; 🇨🇦 Ste-Foy, Quebec, Canada

Cool Aid Community Health Centre; 🇨🇦 Victoria, British Columbia, Canada