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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00301561
First received: March 10, 2006
Last updated: December 2, 2011
Last verified: December 2011

March 10, 2006
December 2, 2011
May 2006
April 2010   (final data collection date for primary outcome measure)
Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy
Complete list of historical versions of study NCT00301561 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Survival probability [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
  • Probability of treatment interruption [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
  • Probability of patients lost to follow-up [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
  • Incidence of side effects [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
  • Incidence of clinical events (WHO stage III or IV) [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
  • Percentage of adherence [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Percentage of patients with drug resistance [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Acceptability by the patients and health professionals of both approaches [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Impact on patients' daily life [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
  • Cost-effectiveness ratio [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Percentage of patients with viral load below 400 copies/ml and 50 copies/ml, respectively (Abbott RealTime HIV-1)
  • Survival probability
  • Probability of treatment interruption
  • Probability of patients lost to follow-up
  • Incidence of side effects
  • Incidence of clinical events (WHO stage III or IV)
  • Percentage of adherence
  • Percentage of patients with drug resistance
  • Acceptability by the patients and health professionals of both approaches
  • Impact on patients' daily life
  • Cost-effectiveness ratio
Not Provided
Not Provided
 
Antiretroviral Treatment Simplified Follow-up Management Assessment (ANRS 12110 STRATALL)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
  • 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
  • Experimental: 1
    Simplify treatment follow-up
    Intervention: Procedure: Simplified follow-up approach of ARV treatment
  • No Intervention: 2
    Standard treatment follow-up
    Intervention: Procedure: Standard follow-up approach of ARV treatment
Laurent C, Kouanfack C, Laborde-Balen G, Aghokeng AF, Mbougua JB, Boyer S, Carrieri MP, Mben JM, Dontsop M, Kazé S, Molinari N, Bourgeois A, Mpoudi-Ngolé 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):825-33. doi: 10.1016/S1473-3099(11)70168-2. Epub 2011 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
459
October 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT00301561
ANRS 12110 STRATALL
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
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
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP