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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00143728
• Other study ID #: P03-0051
• Secondary ID: CTN 189
• Status: Suspended
• Phase: Phase 4
• First received: August 31, 2005
• Last updated: September 24, 2008
• Start date: January 2004
• Est. completion date: May 2010

Study information

• Verified date: September 2008
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 152
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine
See Detailed Description.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Centre Hospitalier de l'université de Laval	Ste-Foy	Quebec
Canada	Haven Program	Sudbury	Ontario
Canada	Maple Leaf Clinic	Toronto	Ontario
Canada	Sunnybrook Hospital	Toronto	Ontario
Canada	Downtown IDC	Vancouver	British Columbia
Canada	Cool Aid Community Health Centre	Victoria	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	CIHR Canadian HIV Trials Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percent and absolute change in viral load from baseline to week 24 and week 48.		48 weeks	No
Secondary	Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.		48 weeks	No