Clinical trial NCT00143728: 3TC or No 3TC for HIV With 3TC Resistance
Official title: A Randomized Study to Evaluate Virologic Response Following Discontinuation vs. no Discontinuation of 3TC in Patients Who Are Infected With HIV With Previously Documented Reduced Susceptibility to 3TC and Who Have Adequate Virologic Suppression on Combination Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
Treatment Experienced
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: CIHR Canadian HIV Trials Network
First posted: 2005-09-02
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: Percent and absolute change in viral load from baseline to week 24 and week 48.
timeFrame: 48 weeks
measure: Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Downtown IDC
state: British Columbia
city: Victoria
country: Canada
facility: Cool Aid Community Health Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Sudbury
country: Canada
facility: Haven Program
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Clinic
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Ste-Foy
country: Canada
facility: Centre Hospitalier de l'université de Laval
state: Quebec
Study officials:
affiliation: University of British Columbia/Providence Health Care
name: Julio Montaner, MD
role: PRINCIPAL_INVESTIGATOR
References: