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

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

Status

Suspended

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143728

Enrollment

152

Registered

2005-09-02

Start date

2004-01-31

Completion date

2010-05-31

Last updated

2008-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Treatment Experienced

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.

Interventions

DRUGLamivudine

See Detailed Description.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026