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
  Purpose

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.


Condition Intervention Phase
HIV Infections
AIDS
Procedure: Simplified follow-up approach of ARV treatment
Procedure: Standard follow-up approach of ARV treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Expanded Access to Antiretroviral Therapy in Africa: Assessment of the Patients' Management in District Hospitals With a Simplified Follow-up Approach (ANRS 12110 STRATALL)

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome 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 ] [ 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 ]

Enrollment: 459
Study Start Date: May 2006
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301561

Locations
Cameroon
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
Yaounde, Cameroon
Sponsors and Collaborators
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
  More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00301561     History of Changes
Other Study ID Numbers: ANRS 12110 STRATALL
Study First Received: March 10, 2006
Last Updated: December 2, 2011
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Antiretroviral treatment
Expanded access
Africa
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014