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Maternal-fetal Infection TransmissionPhase 2MONOGESTNCT02738502

Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors

A Phase 2 study testing darunavir monotherapy in people with Maternal-fetal Infection Transmission, run by ANRS, Emerging Infectious Diseases at 23 sites in France.

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 overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as treatment simplification (switch) in pretreated pregnant women, associated with neonatal prophylaxis with nevirapine, constituting a PMTCT strategy without any Nucleoside Reverse Transcriptase Inhibitor (NRTIs) . Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Maternal-fetal Infection Transmission
What is being tested?
darunavir monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
23 sitesFrance
Study dates
6 Jul 2016to 16 Jul 2020
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant woman, under 15 weeks gestational age at screening
  • Documented Human Immunodeficiency Virus (HIV) HIV-1 infection (serology and/or plasma HIV RNA viral load)
  • Current treatment with at least two ARVs
  • Virological suppression for at least 12 months, defined by a PVL < 50 copies / mL. A blip (transiently ≥ 50 but < 400 copies/mL) will not be considered as an exclusion criterion, if it is followed by 2 successive controls with CV < 50 at least one month before enrollment
  • Plasma viral load < 50 copies/mL at pre-inclusion
  • CD4 ≥ 250 cells/mm3 at pre-inclusion
Show all 10Show fewer
  • Informed written consent
  • Health care coverage
  • Mother enrolled in the trial
  • Informed written consent by parents or legal guardians

Who cannot join

  • Infection by HIV-2
  • History of treatment failure and/or resistance with any Protease Inhibitor (PI). Treatment failure is defined by a viral replication (≥ 50 copies/mL) during antiretroviral treatment. An increasing CV due to treatment interruption will not be considered as a failure, providing that the absence of resistance mutations to at least one PI can be confirmed by genotyping.
  • Documented CD4 lymphocyte less than 200/mm3
  • Known intolerance to darunavir or ritonavir
  • Hepatitis B Virus (HBV) co-infection (HBs Ag-positive and/or detectable HBV DNA) on therapy with analogs (tenofovir, emtricitabine, lamivudine)
  • Known resistance of maternal viral strain to darunavir or nevirapine
Show all 11Show fewer
  • Intended absence (travel abroad, moving ...)
  • Expected delivery in a maternity hospital not participating in the trial
  • Participation in the trial during previous pregnancy
  • Persons under guardianship or deprived of liberty by a judicial or administrative decision
  • Refusal by parent (s) or legal guardian (s)

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • CH Victor Dupouy

    Argenteuil, 95100

  • Hôpital Jean Verdier

    Bondy, 93140

  • Groupe hospitalier Pellegrin

    Bordeaux, 33000

  • Hôpital Saint André

    Bordeaux, 33075

  • Hôpital Antoine Béclère

    Clamart, 92140

  • Hôpital Louis Mourier

    Colombes, 92700

  • Hôpital Sud Francilien

    Corbeil-Essonnes, 91106

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Hôpital de la croix Rousse

    Lyon, 69307

  • Hôtel Dieu

    Nantes, 44093

  • CHU Archet 1

    Nice, 06202

  • Hôpital Lariboisiere

    Paris, 75010

  • Hôpital Armand Trousseau

    Paris, 75012

  • Hôpital la Pitié Salpétrière

    Paris, 75013

  • Groupe hospitalier Cochin-Broca- Hôtel Dieu

    Paris, 75014

  • HEGP

    Paris, 75015

  • Hôpital Necker Enfant malades

    Paris, 75015

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

  • Hôpital Tenon

    Paris, 75020

  • CHU de Perpignan

    Perpignan, 66046

  • CHU Rennes Hôpital Pontchaillou

    Rennes, 35000

  • Hôpital Foch

    Suresnes, 92151

  • CHU Toulouse

    Toulouse, 31059

Other trials in France

About this study

Official title: An Open-label Phase II Pilot Study of Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors

The overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as treatment simplification (switch) in pretreated pregnant women, associated with neonatal prophylaxis with nevirapine, constituting a PMTCT strategy without any Nucleoside Reverse Transcriptase Inhibitor (NRTIs) .

Read the detailed description

90 participants will be enrolled and switch to darunavir monotherapy early in pregnancy (before 16 weeks of amenorrhea) in order to reduce exposure to the antiretroviral nucleos(t)ide analogues. The study treatment during the pregnancy is: darunavir 600 mg + ritonavir 100 mg 2 times 24 (DRV/r) monotherapy This regimen will be started after checking the tolerance of DRV/r 600 mg/100 mg twice daily (recommended dosage for pregnancy in French national recommendations) to replace whatever prior antiretrovirals (ARVs) were used, while maintaining the NRTI backbone for 2 weeks. Woman already receiving a triple drug combination with DRV/r will proceed directly to treatment simplification. If clinical tolerance of DRV/r is satisfactory after 2 weeks, nucleos(t)ides will be stopped. In case of intolerance, the treatment will be determined by the investigator but follow-up of the patient will continue.

No zidovudine will be administered at delivery in case of virological control, according to French Guidelines (Morlat Report 2015).

After delivery, the choice of maternal antiretrovial therapy (ART) is left to the discretion of the clinician and patient.

The mothers are followed up monthly until delivery and the last visit is planes at W4-W6 postpartum. Virological efficacy and safety will be assessed monthly.

In neonates, the prophylactic treatment, nevirapine oral solution, will be administrated as soon as possible in the first 12 hours of life and then for 14 days, once a day at a daily dose of 15 mg for a birthweight ≥ 2.5 kg ; 10 mg for a birthweight ≥ 2 kg and < 2.5 kg and 2 mg / kg for a birthweight < 2 kg (WHO Guidelines 2013 - French Guidelines, "Morlat Report" 2015).

Clinical and virological monitoring will be performed at Day 3, Day 15 in case of hospitalization, M1, M3 and M6.

Statistical Methods The analysis of the primary endpoint is the proportion of virological success (VL < 50 copies/mL at delivery among women remaining on DRV/r). All changes in antiretroviral therapy because of VL ≥ 50 copies/ml will be considered as failures. Women who change antiretroviral therapy for other reasons and/or when pregnancy outcome is before 22 weeks of amenorrhea and < 500g (non-viable pregnancy according to WHO) will be removed from the denominator.

Analysis of treatment changes, tolerance for the mother and child and factors associated with virological failure will be done by estimating percentages (categorical variables), average and median (continuous variables) with their intervals 95% confidence, overall and compared between the groups with virological success or failure per protocol (primary endpoint) or by intention to treat (secondary endpoint). The evolution of the parameters measured in children at birth, at 1, 3, and 6, months will be explored using non-parametric curves and compared between groups by repeated data taking into account the nonlinearity developments.

No interim analysis is planned.

Being tested
darunavir monotherapy
Keywords
HIV, prevention of mother-to-child transmission, Ritonavir boosted darunavir monotherapy

What participants receive

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

  • darunavir monotherapyDrug

    Also called ritonavir

    darunavir 600 mg + ritonavir 100 mg 2 times 24 (DRV/r) monotherapy started after checking the tolerance of DRV/r600 mg/100 mg twice daily to replace whatever prior ARVs were used, while maintaining the NRTI backbone for 2 weeks.

Study groups in NCT02738502
Study groupRoleWhat they receive
Single GroupExperimentalIntervention: Darunavir monotherapy darunavir/ritonavir 600 mg/100mg twice day in monotherapy.
Receives: Drug: darunavir monotherapy

What is being measured

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

  1. Success rate, defined by plasma viral load (PVL) <50 copies / mL near delivery with DRV/r monotherapy. Failure is defined as PVL > 50 copies / mL and/or change of antiretroviral therapy during pregnancy for PVL ≥ 50 copies / mL.

    Measured: At delivery (around 6 months after enrollment in the study).

Secondary outcomes (17)

  1. Plasma viral load (PVL) <50 copies / mL at delivery, Intention-to-treat (ITT) analysis

    Measured: At delivery (around 6 months after enrollment in the study).

  2. Incidence of treatment changes for inefficacy, defined as PVL≥ 50 copies / mL at 2 successive controls.

    Measured: Every month from Month1 up to the delivery.

  3. Incidence of treatment changes for intolerance / toxicity.

    Measured: Every month from Month1 up to the delivery.

  4. Incidence of treatment changes for other reasons.

    Measured: Every month from Month1 up to the delivery.

  5. Factors associated with inefficacy (HIV-1 DNA). Inefficacy is defined as maternal plasma viral load > 50 copies/mL at delivery and/or change of antiretroviral therapy at any time from enrollment through delivery for plasma viral load > 50 copies/mL.

    The following quantitative variables will be compared between women with inefficacy and those with virological success (plasma viral load < 50 copies/mL under darunavir/ritonavir) : HIV-1 DNA (total HIV-DNA log10 copies/million peripheral blood mononuclear cells by the ANRS technique).

    Measured: Every month from Month1 up to the delivery.

  6. Factors associated with inefficacy (lymphocytes T CD4+ count).

    Inefficacy is defined as maternal plasma viral load > 50 copies/mL at delivery and/or change of antiretroviral therapy at any time from enrollment through delivery for plasma viral load > 50 copies/mL. The following quantitative variables will be compared between women with inefficacy and those with virological success (plasma viral load < 50 copies/mL under darunavir/ritonavir) : CD4+ lymphocyte count/microL.

    Measured: Every month from Month1 up to the delivery.

  7. Factors associated with inefficacy (CD4 nadir). Inefficacy is defined as maternal plasma viral load > 50 copies/mL at delivery and/or change of antiretroviral therapy at any time from enrollment through delivery for plasma viral load > 50 copies/mL.

    The following quantitative variables will be compared between women with inefficacy and those with virological success (plasma viral load < 50 copies/mL under darunavir/ritonavir) : CD4+ lymphocyte/microL nadir.

    Measured: Every month from Month1 up to the delivery.

  8. Factors associated with inefficacy (duration of undetectable plasma viral load before pregnancy).

    Inefficacy is defined as maternal plasma viral load > 50 copies/mL at delivery and/or change of antiretroviral therapy at any time from enrollment through delivery for plasma viral load > 50 copies/mL. The following quantitative variables will be compared between women with inefficacy and those with virological success (plasma viral load < 50 copies/mL under darunavir/ritonavir) : duration of undetectable plasma viral load before pregnancy (months).

    Measured: Every month from Month1 up to the delivery.

  9. Adverse pregnancy outcomes (preterm birth)

    preterm birth : < 37 weeks gestational age from last menstrual period)

    Measured: At delivery

  10. Adverse pregnancy outcomes (fetal loss)

    Fetal loss defined as all stillbirths and spontaneous abortions before 22 weeks gestation

    Measured: Every month from Month1 up to the delivery.

  11. Adverse pregnancy outcomes (low birth weight)

    low birth weight < 3d percentile adjusted for gestational age and sex

    Measured: At delivery

  12. Adverse pregnancy outcomes (low Apgar : < 7 at 5 minutes)

    Measured: At delivery

  13. Adverse pregnancy outcomes (congenital malformations)

    Malformations according to the European Surveillance of Congenital Anomalies (EUROCAT) classification)

    Measured: At delivery

  14. Tolerance in children (hematological examinations).

    Hemoglobin, red blood cell count, white blood cell counts and differentials and platelet counts /microL, and mean corpuscular volume in fL

    Measured: At delivery, Day 3, 15, Month1, 3 and 6

  15. Tolerance in children (biochemical examinations).

    AST and ALT, total bilirubin, lipase, sodium, potassium, urea, creatinine, calcium, phosphorus, lactates

    Measured: At delivery, Day 3, 15, Month1, 3 and 6

  16. Interruption rate of postnatal nevirapine (NVP) within 2 weeks of life and patterns;

    Measured: Day 3, Day15

  17. Any case of mother to child transmission would be considered a serious adverse event (SAE) and analyzed immediately.

    Measured: Day 3, Month1, Month 3 and Month 6.

Timeline

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

  1. First posted14 Apr 2016 (estimated)
  2. Study start6 Jul 2016
  3. Primary completion16 Jul 2019
  4. Study completion16 Jul 2020

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738502
Sponsor's protocol ID
ANRS 168 MONOGEST
Other IDs
2015-002542-31, 2015
Acronym
MONOGEST
Status last verified
Aug 2021
First submitted
23 Mar 2016
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Arribas JR, Girard PM, Paton N, Winston A, Marcelin AG, Elbirt D, Hill A, Hadacek MB. Efficacy of protease inhibitor monotherapy vs. triple therapy: meta-analysis of data from 2303 patients in 13 randomized trials. HIV Med. 2016 May;17(5):358-67. doi: 10.1111/hiv.12348. Epub 2015 Dec 28.

    PubMed 26709605

  • Tubiana R, Mandelbrot L, Le Chenadec J, Delmas S, Rouzioux C, Hirt D, Treluyer JM, Ekoukou D, Bui E, Chaix ML, Blanche S, Warszawski J; ANRS 135 PRIMEVA (Protease Inhibitor Monotherapy Evaluation) Study Group. Lopinavir/ritonavir monotherapy as a nucleoside analogue-sparing strategy to prevent HIV-1 mother-to-child transmission: the ANRS 135 PRIMEVA phase 2/3 randomized trial. Clin Infect Dis. 2013 Sep;57(6):891-902. doi: 10.1093/cid/cit390. Epub 2013 Jun 12.

    PubMed 23766338

  • Andre-Schmutz I, Dal-Cortivo L, Six E, Kaltenbach S, Cocchiarella F, Le Chenadec J, Cagnard N, Cordier AG, Benachi A, Mandelbrot L, Azria E, Bouallag N, Luce S, Ternaux B, Reimann C, Revy P, Radford-Weiss I, Leschi C, Recchia A, Mavilio F, Cavazzana M, Blanche S. Genotoxic signature in cord blood cells of newborns exposed in utero to a Zidovudine-based antiretroviral combination. J Infect Dis. 2013 Jul 15;208(2):235-43. doi: 10.1093/infdis/jit149. Epub 2013 Apr 4.

    PubMed 23559464

  • Hleyhel M, Goujon S, Delteil C, Vasiljevic A, Luzi S, Stephan JL, Reliquet V, Jannier S, Tubiana R, Dollfus C, Faye A, Mandelbrot L, Clavel J, Warszawski J, Blanche S; ANRS French Perinatal Cohort Study Group. Risk of cancer in children exposed to didanosine in utero. AIDS. 2016 May 15;30(8):1245-56. doi: 10.1097/QAD.0000000000001051.

    PubMed 26854809

  • Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.

    PubMed 26197844

  • Valantin MA, Lambert-Niclot S, Flandre P, Morand-Joubert L, Cabie A, Meynard JL, Ponscarme D, Ajana F, Slama L, Curjol A, Cuzin L, Schneider L, Taburet AM, Marcelin AG, Katlama C; MONOI ANRS 136 Study Group. Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study. J Antimicrob Chemother. 2012 Mar;67(3):691-5. doi: 10.1093/jac/dkr504. Epub 2011 Dec 7.

    PubMed 22160145

  • Lambert-Niclot S, Flandre P, Valantin MA, Soulie C, Fourati S, Wirden M, Sayon S, Pakianather S, Bocket L, Masquelier B, Dos Santos G, Katlama C, Calvez V, Marcelin AG. Similar evolution of cellular HIV-1 DNA level in darunavir/ritonavir monotherapy versus triple therapy in MONOI-ANRS136 trial over 96 weeks. PLoS One. 2012;7(7):e41390. doi: 10.1371/journal.pone.0041390. Epub 2012 Jul 25.

    PubMed 22848481

  • Mandelbrot L, Tubiana R, Frange P, Peytavin G, Le Chenadec J, Canestri A, Morlat P, Brunet-Cartier C, Sibiude J, Peretti D, Chambrin V, Chabrol A, Bui E, Simon-Toulza C, Marchand L, Paul C, Delmas S, Avettand-Fenoel V, Warszawski J; Monogest study group. Maintenance darunavir/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE 168 MONOGEST study. J Antimicrob Chemother. 2023 Jul 5;78(7):1711-1722. doi: 10.1093/jac/dkad161.

    PubMed 37248782

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing darunavir monotherapy in people with Maternal-fetal Infection Transmission, run by ANRS, Emerging Infectious Diseases at 23 sites in France.

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 10 inclusion and 11 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Success rate, defined by plasma viral load (PVL) <50 copies / mL near delivery with DRV/r monotherapy. Failure is defined as PVL > 50 copies / mL and/or change of antiretroviral therapy during pregnancy for PVL ≥ 50 copies / mL. (time frame: At delivery (around 6 months after enrollment in the study).). 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 NCT02738502, which also lists 8 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 7 Apr 2026.

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