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

• 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 ]
  

• 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 ]
  

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.