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

University of British Columbia

Status and phase: Suspended; Phase 4

Conditions: HIV Infections

Treatments: Drug: Lamivudine

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00143728

P03-0051

CTN 189

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)