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

NCT00301561 | Completed Phase 3 DMC

• 1 other identifier: ANRS 12110 STRATALL
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 9

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.

Conditions

HIV Infections; AIDS

Keywords

Antiretroviral treatment; Expanded access; Africa; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy

  24 months

Secondary Outcomes (11)

• Percentage of patients with viral load below 400 copies/ml and 50 copies/ml, respectively (Abbott RealTime HIV-1)

  12 and 24 months

• Survival probability

  Through out the trial

• Probability of treatment interruption

  Through out the trial

• Probability of patients lost to follow-up

  Through out the trial

• Incidence of side effects

  Through out the trial

Study Arms (2)

1

EXPERIMENTAL

Simplify treatment follow-up

Procedure: Simplified follow-up approach of ARV treatment

2

ACTIVE COMPARATOR

Standard treatment follow-up

Procedure: Standard follow-up approach of ARV treatment

Interventions

Simplified follow-up approach of ARV treatment 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

1

Standard follow-up approach of ARV treatment 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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (9)

Hôpital de district d'Ayos

Ayos, Cameroon

Location

Hôpital de district de Bafia

Bafia, Cameroon

Location

Hôpital de district de Mfou

Mfou, Cameroon

Location

Hôpital de district de Monatélé

Monatélé, Cameroon

Location

Hôpital de district de Nanga Eboko

Naga Eboko, Cameroon

Location

Hôpital de district de Ndikiniméki

Ndikiniméki, Cameroon

Location

Hôpital de district d'Obala

Obala, Cameroon

Location

Hôpital de district de Sa'a

Sa'a, Cameroon

Location

Hôpital de district de Mbalmayo

Yaoundé, Cameroon

Location

Related Publications (2)

• 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.

  PMID: 35248123 DERIVED

• 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.

  PMID: 21831714 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 13, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

CA (9)