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Antiretroviral Treatment Simplified Follow-up Management Assessment (ANRS 12110 STRATALL)

NCT00301561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2016-07-22

No results posted yet for this study

Summary

Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians…), WHO has developed a follow-up approach based on a simplified monitoring. However, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.

Conditions

  • HIV Infections
  • AIDS

Interventions

PROCEDURE

Simplified follow-up approach of ARV treatment

Simplify treatment follow-up : * some clinical consultations will be performed by nurses under the physicians' responsibility ; * the CD4 cell count and HIV-1 viral load will not be available for the management of patients ; * the biologic assessment for tolerability will be limited

PROCEDURE

Standard follow-up approach of ARV treatment

Standard treatment follow-up : * all clinical consultations will be performed by physicians ; * the CD4 cell count and HIV-1 viral load will be available for the patients management routinely ; * the biologic assessment for tolerability will be available as needed

Sponsors & Collaborators

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Christian Laurent · Institut de Recherche pour le Developpement

  • Eric Delaporte · Institut de Recherche pour le Developpement

  • Sinata Koulla-Shiro · Hôpital Central, Yaoundé, Cameroun

  • Charles Kouandack · Hôpital Central, Yaoundé, Cameroun

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-04-30
Completion
2010-10-31

Countries

  • Cameroon

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 NCT00301561 on ClinicalTrials.gov