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

NCT ID: NCT00301561

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-10-31

Brief 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.

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.

Conditions

HIV Infections; AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Simplify treatment follow-up

Group Type: EXPERIMENTAL

Simplified follow-up approach of ARV treatment

Intervention Type: PROCEDURE

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

2

Standard treatment follow-up

Group Type: ACTIVE_COMPARATOR

Standard follow-up approach of ARV treatment

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Laurent

Role: STUDY_CHAIR

Institut de Recherche pour le Developpement

Eric Delaporte

Role: STUDY_CHAIR

Institut de Recherche pour le Developpement

Sinata Koulla-Shiro

Role: STUDY_CHAIR

Hôpital Central, Yaoundé, Cameroun

Charles Kouandack

Role: STUDY_CHAIR

Hôpital Central, Yaoundé, Cameroun

Locations

Hôpital de district d'Ayos

Ayos, , Cameroon

Hôpital de district de Bafia

Bafia, , Cameroon

Hôpital de district de Mfou

Mfou, , Cameroon

Hôpital de district de Monatélé

Monatélé, , Cameroon

Hôpital de district de Nanga Eboko

Naga Eboko, , Cameroon

Hôpital de district de Ndikiniméki

Ndikiniméki, , Cameroon

Hôpital de district d'Obala

Obala, , Cameroon

Hôpital de district de Sa'a

Sa'a, , Cameroon

Hôpital de district de Mbalmayo

Yaoundé, , Cameroon

Countries

Cameroon

References

Sandie AB, Molinari N, Wanjoya A, Kouanfack C, Laurent C, Tchatchueng-Mbougua JB. Non-inferiority test for a continuous variable with a flexible margin in an active controlled trial: an application to the "Stratall ANRS 12110 / ESTHER" trial. Trials. 2022 Mar 5;23(1):202. doi: 10.1186/s13063-022-06118-x.

Reference Type: DERIVED

PMID: 35248123 (View on PubMed)

Laurent C, Kouanfack C, Laborde-Balen G, Aghokeng AF, Mbougua JBT, Boyer S, Carrieri MP, Mben JM, Dontsop M, Kaze S, Molinari N, Bourgeois A, Mpoudi-Ngole E, Spire B, Koulla-Shiro S, Delaporte E; Stratall ANRS 12110/ESTHER study group. Monitoring of HIV viral loads, CD4 cell counts, and clinical assessments versus clinical monitoring alone for antiretroviral therapy in rural district hospitals in Cameroon (Stratall ANRS 12110/ESTHER): a randomised non-inferiority trial. Lancet Infect Dis. 2011 Nov;11(11):825-833. doi: 10.1016/S1473-3099(11)70168-2. Epub 2011 Aug 8.

Reference Type: DERIVED

PMID: 21831714 (View on PubMed)

Other Identifiers

ANRS 12110 STRATALL

Identifier Type: -

Identifier Source: org_study_id