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

July 20, 2016 updated by: French National Agency for Research on AIDS and Viral Hepatitis

Expanded Access to Antiretroviral Therapy in Africa: Assessment of the Patients' Management in District Hospitals With a Simplified Follow-up Approach (ANRS 12110 STRATALL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Justification

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. This "simplified" approach restricting the use of complementary exams including biologic criteria of effectiveness and tolerability, some people consider this approach as dangerous for the patient but also for the community (rapid emergence of resistances) and that it would be preferable to treat less patients and only with the gold standard approach. In practice, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.

Objectives

Main objective: To compare the increase in the CD4 cell count in patients receiving ART with a "simplified" approach and in those treated with the gold standard approach in district hospitals.

Secondary objectives: To compare between the two approaches the virologic effectiveness, survival, treatment interruptions, number of patients lost to follow-up, clinical progression, clinical and biologic tolerability, adherence, emergence of drug resistances, impact on patients' daily life, acceptability by the patients and health professionals, and cost-effectiveness performances.

Methods

Randomised, controlled, multicentre, non inferiority, intervention trial, without blind for approach, in 9 district hospitals of the Province du Centre in Cameroon. 430 adult patients will be randomised in two groups ("simplified" approach or gold standard approach) with a 1:1 ratio and followed for 24 months.

In the "simplified" approach, the results of the HIV-1 viral load and CD4 cell count will not be available for the management of patients, the biologic assessment of tolerability will be limited and some clinical consultations will be performed by nurses under the physicians' responsibility; the remainder will be similar to the gold standard approach.

Planning

The study will start in the first semester of 2006. The full length of the study would be 36 months maximum (12 months for enrolment and 24 months for follow-up).

Expected results

Advices for increasing access to ART in Africa.

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Ayos, Cameroon
        • Hôpital de district d'Ayos
      • Bafia, Cameroon
        • Hôpital de district de Bafia
      • Mfou, Cameroon
        • Hôpital de district de Mfou
      • Monatélé, Cameroon
        • Hôpital de district de Monatélé
      • Naga Eboko, Cameroon
        • Hôpital de district de Nanga Eboko
      • Ndikiniméki, Cameroon
        • Hôpital de district de Ndikiniméki
      • Obala, Cameroon
        • Hôpital de district d'Obala
      • Sa'a, Cameroon
        • Hôpital de district de Sa'a
      • Yaounde, Cameroon
        • Hôpital de district de Mbalmayo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women aged at least 18 years
  • Living in the health district of the hospital attended
  • Confirmed HIV-1 group M infection

  • Meeting one of the following criteria:

    • Stage III or IV (WHO classification)
    • Stage II (WHO classification) and total lymphocytes count ≤ 1200/mm3
  • Patient agreeing on monthly follow-up and treatment for 24 months
  • Signed informed consent

Exclusion Criteria:

  • HIV-1 group O or N, or HIV-2 infection
  • HIV-1 primary infection
  • Progressive tuberculosis in treatment and total lymphocytes count > 1200/mm3
  • Progressive tumor or malignant lymphoma (except cutaneous or mucous Kaposi sarcoma)
  • Progressive psychiatric disorder
  • Hepatocellular disorder
  • History of antiretroviral therapy
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Simplify treatment follow-up
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
Active Comparator: 2
Standard treatment follow-up
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with viral load below 400 copies/ml and 50 copies/ml, respectively (Abbott RealTime HIV-1)
Time Frame: 12 and 24 months
12 and 24 months
Survival probability
Time Frame: Through out the trial
Through out the trial
Probability of treatment interruption
Time Frame: Through out the trial
Through out the trial
Probability of patients lost to follow-up
Time Frame: Through out the trial
Through out the trial
Incidence of side effects
Time Frame: Through out the trial
Through out the trial
Incidence of clinical events (WHO stage III or IV)
Time Frame: Through out the trial
Through out the trial
Percentage of adherence
Time Frame: 12 and 24 months
12 and 24 months
Percentage of patients with drug resistance
Time Frame: 12 and 24 months
12 and 24 months
Acceptability by the patients and health professionals of both approaches
Time Frame: 12 and 24 months
12 and 24 months
Impact on patients' daily life
Time Frame: Through out the trial
Through out the trial
Cost-effectiveness ratio
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

  • Study Chair: Christian Laurent, Institut de Recherche pour le Developpement
  • Study Chair: Eric Delaporte, Institut de Recherche pour le Developpement
  • Study Chair: Sinata Koulla-Shiro, Hôpital Central, Yaoundé, Cameroun
  • Study Chair: Charles Kouandack, Hôpital Central, Yaoundé, Cameroun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria

March 10, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12110 STRATALL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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