AzTrials
AzTrials

HIV InfectionsPhase 2/3NCT01127204

Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age

A Phase 2/3 study testing AZT-3TC-LPV/r twice a day and ABC-3TC-EFV once a day in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 4 sites in 2 countries.

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

The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. Read more about this study

Who is it for?
Ages 3 to 12 months
Conditions the study is for
HIV Infections
What is being tested?
AZT-3TC-LPV/r twice a day and ABC-3TC-EFV once a day
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
4 sitesin 2 countries
Study dates
Jun 2011to Apr 2015
Phase
Phase 2/3
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 3 to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • infant follow-up in one of the trial site
  • HIV-1 infection diagnose by RT PCR after 6 weeks of life
  • age between 3 and 12 month at the antiretroviral treatment initiation
  • naive of antiretrovirals except if received for the prevention of mother to child HIV transmission
  • HB>=7 g/dl, neutrophiles>750/mm3, creatinin<3xULN, TGO and TGP<3xULN
  • signed informed consent

Who cannot join

  • HIV-2 infection or HIV-1/HIV-2 co-infection
  • Known intolerance to one of the trial treatment
  • HB<7 g/dl, neutrophiles<750/mm3, creatinin>3xULN, TGO or TGP>3xULN
  • Inclusion Criteria for randomisation at 12 months in the simplification phase:
  • age 24 months at most
  • virological success define as 2 consecutive indetectable HIV RNA measured by RT PCR at least 3 months apart.
  • Exclusion Criteria for randomisation at 12 months in the simplification phase:
  • virological failure after the first 12 months of antiretroviral treatment

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Burkina Faso2 sites

  • Service de maladies infectieuses - CHU Charles de Gaulle

    Ouagadougou

  • Service de pédiatrie - CHU Yalgado Ouedraogo

    Ouagadougou

Other trials in Burkina Faso

Côte d’Ivoire2 sites

  • CEPREF

    Abidjan

  • FSU abobo-Avocatier

    Abidjan

Other trials in Côte d’Ivoire

About this study

Official title: Randomized Phase 3 Trial to Evaluate Two Simplified Antiretroviral Treatment Strategies in HIV Infected Children, Treated by Antiretroviral Triple Therapy Before One Year of Age, in Virological Success in Africa (Burkina Faso, Côte d'Ivoire, Rwanda)

The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once daily.

The perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.

Conditions
HIV Infections
Being tested
AZT-3TC-LPV/r twice a day, ABC-3TC-EFV once a day
Keywords
HIV, Antiretroviral therapy, Infant, Sub Saharian Africa
Medical subject headings
HIV Infections

What participants receive

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

  • AZT-3TC-LPV/r twice a dayDrug

    AZT sirup (10mg/ml): 4 mg/kg or 180 mg/m2 twice daily 3TC sirup (10mg/ml): 4 mg/kg twice daily LPV/r sirup (80/20 mg/ml): 12 mg/kg twice daily

  • ABC-3TC-EFV once a dayDrug

    ABC sirup (20mg/ml): 16 mg/kg once daily in the morning 3TC sirup (10mg/ml): 8 mg/kg once daily in the morning EFV sirup (30mg/ml): 25 mg/kg once daily in the morning before food intake

Study groups in NCT01127204
Study groupRoleWhat they receive
arm 1 (reference strategy)Active comparatorAZT-3TC-LPV/r twice a day
Receives: Drug: AZT-3TC-LPV/r twice a day
arm 2 (simplification strategy)ExperimentalABC-3TC-EFV once a day
Receives: Drug: ABC-3TC-EFV once a day

What is being measured

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

  1. Initial therapeutic cohort: Virological success

    survival without virological failure (death or loss of follow-up or virologic failure, i.e. HIV-ARN ≥400 copies/mL on one consecutive sample), analysis of resistance profile.

    Measured: 12 months

  2. Randomised simplification phase: Virological success

    survival without virological failure (death or loss of follow-up or virologic failure (HIV-ARN ≥400 copies/mL ))from M13 to M25.

    Measured: 25 months

Secondary outcomes (6)

  1. Virological success

    HIV RNA < 400 copies / mL

    Measured: 12 months

  2. Immunological response

    CD4+ lymphocyte absolute count and percentage

    Measured: 12 and 25 months

  3. Antiretroviral and cotrimoxazol pharmacokinetic parameters

    The following parameters will be measured or calculated: maximal and minimal concentration (Cmax, Cmin), half life (t1/2), Aire Under the Curve (AUC), clearance and volume of distribution, for all antiretroviral (according to treatment arm : AZT, 3TC, LPV, ABC, EFV) and cotimoxazol.

    Measured: 6, 19 and 25 months

  4. Tolerance

    occurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrome

    Measured: 12 and 25 month

  5. Adherence

    measurement at each protocol visit of the three last days treatment intake to be corelated to the antiretroviral concentration and virological success

    Measured: 12 and 25 months

  6. Resistance to antiretroviral

    Genotyping to analyse resistance mutation when virological failure

    Measured: 12 and 25 months

Timeline

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

  1. First posted20 May 2010 (estimated)
  2. Study startJun 2011
  3. Primary completionApr 2015
  4. Study completionApr 2015

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127204
Sponsor's protocol ID
ANRS 12206 MONOD
Other IDs
IP.2007.33011.002
Status last verified
Jul 2016
First submitted
19 May 2010
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Pressiat C, Toni TD, Treluyer JM, Yonaba C, Dahourou DL, Malateste K, Seguin-Devaux C, Leroy V, Hirt D; MONOD ANRS Study Group. High nevirapine levels in breast milk and consequences in HIV-infected child when initiated on antiretroviral therapy. AIDS. 2021 Nov 15;35(14):2409-2410. doi: 10.1097/QAD.0000000000003043. No abstract available.

    PubMed 34723858

  • Desmonde S, Frank SC, Coovadia A, Dahourou DL, Hou T, Abrams EJ, Amorissani-Folquet M, Walensky RP, Strehlau R, Penazzato M, Freedberg KA, Kuhn L, Leroy V, Ciaranello AL. Cost-Effectiveness of Preemptive Switching to Efavirenz-Based Antiretroviral Therapy for Children With Human Immunodeficiency Virus. Open Forum Infect Dis. 2019 Jun 11;6(7):ofz276. doi: 10.1093/ofid/ofz276. eCollection 2019 Jul.

    PubMed 31334298

  • Pressiat C, Mea-Assande V, Yonaba C, Treluyer JM, Dahourou DL, Amorissani-Folquet M, Blanche S, Eboua F, Ye D, Lui G, Malateste K, Zheng Y, Leroy V, Hirt D; MONOD Study Group. Suboptimal cotrimoxazole prophylactic concentrations in HIV-infected children according to the WHO guidelines. Br J Clin Pharmacol. 2017 Dec;83(12):2729-2740. doi: 10.1111/bcp.13397. Epub 2017 Sep 20.

    PubMed 28800382

  • Pressiat C, Amorissani-Folquet M, Yonaba C, Treluyer JM, Dahourou DL, Eboua F, Blanche S, Mea-Assande V, Bouazza N, Foissac F, Malateste K, Ouedraogo S, Lui G, Leroy V, Hirt D. Pharmacokinetics of Efavirenz at a High Dose of 25 Milligrams per Kilogram per Day in Children 2 to 3 Years Old. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00297-17. doi: 10.1128/AAC.00297-17. Print 2017 Jul.

    PubMed 28483965

  • Amani-Bosse C, Dahourou DL, Malateste K, Amorissani-Folquet M, Coulibaly M, Dattez S, Emieme A, Barry M, Rouzioux C, N'gbeche S, Yonaba C, Timite-Konan M, Mea V, Ouedraogo S, Blanche S, Meda N, Seguin-Devaux C, Leroy V. Virological response and resistances over 12 months among HIV-infected children less than two years receiving first-line lopinavir/ritonavir-based antiretroviral therapy in Cote d'Ivoire and Burkina Faso: the MONOD ANRS 12206 cohort. J Int AIDS Soc. 2017 Apr 25;20(1):21362. doi: 10.7448/IAS.20.01.21362.

    PubMed 28453240

  • Dahourou DL, Amorissani-Folquet M, Malateste K, Amani-Bosse C, Coulibaly M, Seguin-Devaux C, Toni T, Ouedraogo R, Blanche S, Yonaba C, Eboua F, Lepage P, Avit D, Ouedraogo S, Van de Perre P, N'Gbeche S, Kalmogho A, Salamon R, Meda N, Timite-Konan M, Leroy V; MONOD Study Group. Efavirenz-based simplification after successful early lopinavir-boosted-ritonavir-based therapy in HIV-infected children in Burkina Faso and Cote d'Ivoire: the MONOD ANRS 12206 non-inferiority randomised trial. BMC Med. 2017 Apr 24;15(1):85. doi: 10.1186/s12916-017-0842-4.

    PubMed 28434406

  • Dahourou DL, Amorissani-Folquet M, Coulibaly M, Avit-Edi D, Meda N, Timite-Konan M, Arendt V, Ye D, Amani-Bosse C, Salamon R, Lepage P, Leroy V; Monod Anrs 12206 Study Group. Missed opportunities of inclusion in a cohort of HIV-infected children to initiate antiretroviral treatment before the age of two in West Africa, 2011 to 2013. J Int AIDS Soc. 2016 Mar 23;19(1):20601. doi: 10.7448/IAS.19.1.20601. eCollection 2016.

    PubMed 27015798

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AZT-3TC-LPV/r twice a day and ABC-3TC-EFV once a day in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 4 sites in 2 countries.

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 6 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 12 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 4 sites in Burkina Faso, Côte d’Ivoire. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Initial therapeutic cohort: Virological success (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01127204, which also lists 7 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 12 Jul 2016.

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