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Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC

NCT00338390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-03-24

No results posted yet for this study

Summary

The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Conditions

  • HIV Infections

Interventions

DRUG

Abacavir

Change tenofovir to abacavir

DRUG

Didanosine

Increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg.

DRUG

Abacavir+Lamivudine

Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).

Sponsors & Collaborators

  • Hospital de Granollers

    lead OTHER

Principal Investigators

  • Enric Pedrol, MD, PhD · Fundació Hospital de Granollers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • Spain

Study Locations

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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 NCT00338390 on ClinicalTrials.gov