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

Overview

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.

Full Title of Study: “Expanded Access to Antiretroviral Therapy in Africa: Assessment of the Patients’ Management in District Hospitals With a Simplified Follow-up Approach (ANRS 12110 STRATALL)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2010

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.

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Simplify treatment follow-up
  • Active Comparator: 2
    • Standard treatment follow-up

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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
  • Survival probability
    • Time Frame: Through out the trial
  • Probability of treatment interruption
    • Time Frame: Through out the trial
  • Probability of patients lost to follow-up
    • Time Frame: Through out the trial
  • Incidence of side effects
    • Time Frame: Through out the trial
  • Incidence of clinical events (WHO stage III or IV)
    • Time Frame: Through out the trial
  • Percentage of adherence
    • Time Frame: 12 and 24 months
  • Percentage of patients with drug resistance
    • Time Frame: 12 and 24 months
  • Acceptability by the patients and health professionals of both approaches
    • Time Frame: 12 and 24 months
  • Impact on patients’ daily life
    • Time Frame: Through out the trial
  • Cost-effectiveness ratio
    • Time Frame: 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • French National Agency for Research on AIDS and Viral Hepatitis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christian Laurent, Study Chair, Institut de Recherche pour le Developpement
    • Eric Delaporte, Study Chair, Institut de Recherche pour le Developpement
    • Sinata Koulla-Shiro, Study Chair, Hôpital Central, Yaoundé, Cameroun
    • Charles Kouandack, Study Chair, Hôpital Central, Yaoundé, Cameroun

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.