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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301561
• Other study ID #: ANRS 12110 STRATALL
• Status: Completed
• Phase: Phase 3
• First received: March 10, 2006
• Last updated: July 20, 2016
• Start date: May 2006
• Est. completion date: October 2010

Study information

• Verified date: July 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

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
• 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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy		24 months	No
Secondary	Percentage of patients with viral load below 400 copies/ml and 50 copies/ml, respectively (Abbott RealTime HIV-1)		12 and 24 months	No
Secondary	Survival probability		Through out the trial	Yes
Secondary	Probability of treatment interruption		Through out the trial	No
Secondary	Probability of patients lost to follow-up		Through out the trial	No
Secondary	Incidence of side effects		Through out the trial	Yes
Secondary	Incidence of clinical events (WHO stage III or IV)		Through out the trial	Yes
Secondary	Percentage of adherence		12 and 24 months	No
Secondary	Percentage of patients with drug resistance		12 and 24 months	No
Secondary	Acceptability by the patients and health professionals of both approaches		12 and 24 months	No
Secondary	Impact on patients' daily life		Through out the trial	No
Secondary	Cost-effectiveness ratio		24 months	No