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HIV InfectionsPhase 3NCT00301561

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

A Phase 3 study testing Simplified follow-up approach of ARV treatment and Standard follow-up approach of ARV treatment in people with HIV Infections and AIDS, run by French National Agency for Research on AIDS and Viral Hepatitis at 9 sites in Cameroon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, AIDS
What is being tested?
Simplified follow-up approach of ARV treatment and Standard follow-up approach of ARV treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
459 participants
Where
9 sitesCameroon
Study dates
May 2006to Oct 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Cameroon9 sites

  • Hôpital de district d'Ayos

    Ayos

  • Hôpital de district de Bafia

    Bafia

  • Hôpital de district de Mfou

    Mfou

  • Hôpital de district de Monatélé

    Monatélé

  • Hôpital de district de Nanga Eboko

    Naga Eboko

  • Hôpital de district de Ndikiniméki

    Ndikiniméki

  • Hôpital de district d'Obala

    Obala

  • Hôpital de district de Sa'a

    Sa'a

  • Hôpital de district de Mbalmayo

    Yaoundé

Other trials in Cameroon

About this 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)

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.

Read the detailed 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.

Conditions
HIV Infections, AIDS
Being tested
Simplified follow-up approach of ARV treatment, Standard follow-up approach of ARV treatment
Keywords
Antiretroviral treatment, Expanded access, Africa, Treatment Naive
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simplified follow-up approach of ARV treatmentProcedure or surgery

    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 treatmentProcedure or surgery

    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
Study groups in NCT00301561
Study groupRoleWhat they receive
1ExperimentalSimplify treatment follow-up
Receives: Procedure: Simplified follow-up approach of ARV treatment
2Active comparatorStandard treatment follow-up
Receives: Procedure: Standard follow-up approach of ARV treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy

    Measured: 24 months

Secondary outcomes (11)

  1. Percentage of patients with viral load below 400 copies/ml and 50 copies/ml, respectively (Abbott RealTime HIV-1)

    Measured: 12 and 24 months

  2. Survival probability

    Measured: Through out the trial

  3. Probability of treatment interruption

    Measured: Through out the trial

  4. Probability of patients lost to follow-up

    Measured: Through out the trial

  5. Incidence of side effects

    Measured: Through out the trial

  6. Incidence of clinical events (WHO stage III or IV)

    Measured: Through out the trial

  7. Percentage of adherence

    Measured: 12 and 24 months

  8. Percentage of patients with drug resistance

    Measured: 12 and 24 months

  9. Acceptability by the patients and health professionals of both approaches

    Measured: 12 and 24 months

  10. Impact on patients' daily life

    Measured: Through out the trial

  11. Cost-effectiveness ratio

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionApr 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301561
Sponsor's protocol ID
ANRS 12110 STRATALL
Status last verified
Jul 2016
First submitted
10 Mar 2006
Last updated
22 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Sandie AB, Molinari N, Wanjoya A, Kouanfack C, Laurent C, Tchatchueng-Mbougua JB. Non-inferiority test for a continuous variable with a flexible margin in an active controlled trial: an application to the "Stratall ANRS 12110 / ESTHER" trial. Trials. 2022 Mar 5;23(1):202. doi: 10.1186/s13063-022-06118-x.

    PubMed 35248123

  • Laurent C, Kouanfack C, Laborde-Balen G, Aghokeng AF, Mbougua JBT, Boyer S, Carrieri MP, Mben JM, Dontsop M, Kaze S, Molinari N, Bourgeois A, Mpoudi-Ngole E, Spire B, Koulla-Shiro S, Delaporte E; Stratall ANRS 12110/ESTHER study group. Monitoring of HIV viral loads, CD4 cell counts, and clinical assessments versus clinical monitoring alone for antiretroviral therapy in rural district hospitals in Cameroon (Stratall ANRS 12110/ESTHER): a randomised non-inferiority trial. Lancet Infect Dis. 2011 Nov;11(11):825-833. doi: 10.1016/S1473-3099(11)70168-2. Epub 2011 Aug 8.

    PubMed 21831714

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Simplified follow-up approach of ARV treatment and Standard follow-up approach of ARV treatment in people with HIV Infections and AIDS, run by French National Agency for Research on AIDS and Viral Hepatitis at 9 sites in Cameroon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00301561, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.

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