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GMB: Study of Truvada (TDF+FTC) or Emtricitabine (FTC) Alone Versus HAART Interruption in HIV-Infected Patients With Resistance

NCT00362687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-03-31

No results posted yet for this study

Summary

Many patients who already harbor drug-resistant HIV require interruption of HAART due to poor compliance, poor quality of life, toxicity or development of resistance. In these patients interruption of HAART has a negative impact on patient immune status due to the reemergence of wild-type virus which is in general more pathogenic than HIV isolates containing resistance mutations. There is a need for "bridging" antiretroviral regimens that might prolong time off conventional HAART whilst waiting for a new regimen that is either fully suppressive or less toxic or less demanding for the patient.

Conditions

  • HIV Infections

Interventions

DRUG

Truvada (TDF+FTC) alone

tenofovir DF 300 mg and emtricitabine 200 mg in a fixed dose tablet formulation

DRUG

FTC alone

emtricitabine 200 mg

PROCEDURE

No HAART

No HAART

Sponsors & Collaborators

Principal Investigators

  • Pedro Ferrer · Gilead Sciences, S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-05-31
Completion
2008-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362687 on ClinicalTrials.gov