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Sponsored by: |
French National Agency for Research on AIDS and Viral Hepatitis |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00301561 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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) |
Enrollment: | 459 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Simplify treatment follow-up
|
Procedure: Simplified follow-up approach of ARV treatment
Simplify treatment follow-up :
|
2: No Intervention
Standard treatment follow-up
|
Procedure: Standard follow-up approach of ARV treatment
Standard treatment follow-up :
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meeting one of the following criteria:
Exclusion Criteria:
Cameroon | |
Hôpital de district d'Ayos | |
Ayos, Cameroon | |
Hôpital de district de Bafia | |
Bafia, Cameroon | |
Hôpital de district de Mbalmayo | |
Yaounde, Cameroon | |
Hôpital de district de Mfou | |
Mfou, Cameroon | |
Hôpital de district de Sa'a | |
Sa'a, 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 Monatélé | |
Monatélé, Cameroon |
Study Chair: | Christian Laurent | Institut de Recherche pour le Développement (IRD), France |
Study Chair: | Eric Delaporte | Institut de Recherche pour le Développement (IRD), France |
Study Chair: | Sinata Koulla-Shiro | Hôpital Central, Yaoundé, Cameroun |
Study Chair: | Charles Kouandack | Hôpital Central, Yaoundé, Cameroun |
Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis ( Claire Rekacewicz ) |
Study ID Numbers: | ANRS 12110 STRATALL |
Study First Received: | March 10, 2006 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00301561 |
Health Authority: | Cameroon: Ministry of Public Health |
Antiretroviral treatment Expanded access Africa Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |