Antiretroviral Treatment Simplified Follow-up Management Assessment (ANRS 12110 STRATALL)
|ClinicalTrials.gov Identifier: NCT00301561|
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : July 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections AIDS||Procedure: Simplified follow-up approach of ARV treatment Procedure: Standard follow-up approach of ARV treatment||Phase 3|
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.
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.
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.
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).
Advices for increasing access to ART in Africa.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||459 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||October 2010|
Simplify treatment follow-up
Procedure: Simplified follow-up approach of ARV treatment
Simplify treatment follow-up :
Active Comparator: 2
Standard treatment follow-up
Procedure: Standard follow-up approach of ARV treatment
Standard treatment follow-up :
- Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy [ Time Frame: 24 months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301561
|Hôpital de district d'Ayos|
|Hôpital de district de Bafia|
|Hôpital de district de Mfou|
|Hôpital de district de Monatélé|
|Hôpital de district de Nanga Eboko|
|Naga Eboko, Cameroon|
|Hôpital de district de Ndikiniméki|
|Hôpital de district d'Obala|
|Hôpital de district de Sa'a|
|Hôpital de district de Mbalmayo|
|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|