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Monitoring Highly Active Antiretroviral Therapy in HIV-infected Parents in Thailand

NCT00162682 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 716

Last updated 2012-01-06

No results posted yet for this study

Summary

The purpose of this study is to determine if a decision to switch to a subsequent antiretroviral regimen based upon the CD4 cell count rather than the standard switching strategy based on viral load could ensure the same immunological and clinical outcome and preserve future treatment options in AIDS patients

Conditions

  • HIV Infections

Interventions

PROCEDURE

Antiretroviral Drug Combination Switching Criteria

Antiretroviral treatment will use the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.

PROCEDURE

Antiretroviral Drug Combination Switching Criteria

Antiretroviral treatment is monitored using a CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Marc Lallemant, MD · Institut de Recherche pour le Developpement & Harvard School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2010-04-30
Completion
2011-12-31

Countries

  • Thailand

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 NCT00162682 on ClinicalTrials.gov