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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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AIDS, HIV Infections

Intervention / Treatment
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* Procedure: Simplified follow-up approach of ARV treatment
* Procedure: Standard follow-up approach of ARV treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Simplify treatment follow-up | Procedure: Simplified follow-up approach of ARV treatment<br>* 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<br>|
| Active Comparator: 2<br>Standard treatment follow-up | Procedure: Standard follow-up approach of ARV treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of clinical events (WHO stage III or IV) |  | Through out the trial | 
| Percentage of adherence |  | 12 and 24 months | 
| Percentage of patients with drug resistance |  | 12 and 24 months | 
| Acceptability by the patients and health professionals of both approaches |  | 12 and 24 months | 
| Impact on patients' daily life |  | Through out the trial | 
| Cost-effectiveness ratio |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiretroviral treatment, Expanded access, Africa, Treatment Naive