HIV InfectionPhase 3UMANCT00936195
Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations for HIV-1 PMTCT in Pregnant and Breastfeeding Women : a Phase 3 Trial
A Phase 3 study testing Efavirenz-Tenofovir-Emtricitabine and Zidovudine-Lamivudine-Lopinavir/Ritonavir in people with HIV Infection and Pregnancy, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 sites in 2 countries.
Trial summary
To assess the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing breastfeeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infection, Pregnancy, Breastfeeding
- What is being tested?
- Efavirenz-Tenofovir-Emtricitabine and Zidovudine-Lamivudine-Lopinavir/Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2010to Jun 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being pregnant, presenting in at least the 20th week of pregnancy and no later than 2 weeks before the expected term;
- at least 18 years of age;
- diagnosed as infected with HIV-1 only;
- not currently taking any ARV drugs;
- having not been exposed to NVP in the 6 months preceding enrolment;
- willing to breastfeed their forthcoming child;
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- residing and planning to continue to reside within the predefined catchment areas until 12 months after delivery;
- being able to give informed consent for enrolment in the study;
- lacking any medical contraindication to any of the proposed ARV medications;
- and accepting the principle of being randomized to receive one of the ARV regimens evaluated within the study, to prevent MTCT and for their own health when required.
Who cannot join
- presenting within 2 weeks before the expected term;
- currently taking ARV drugs;
- having been exposed to NVP in the 6 months preceding enrolment;
- not willing to breastfeed their forthcoming child;
- having severe renal insufficiency (creatin clearance < 60ml/min);
- diagnosed as infected with HIV-2 only or dually infected HIV-1 and HIV-2;
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- hemoglobin < 7 g/dL in the month preceding inclusion
- HBs Ag positive
- Women meeting one of the three last exclusion criteria (HIV-2 infection or co-infection, hemoglobin < 7 g/dL, HBs Ag positive) will not be randomized but will all received Atripla and be followed-up in an ancillary open cohort according the same procedures and agenda.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety and Efficacy of the Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations in Pregnant and Breastfeeding Women to Prevent mother-to Child Transmission of HIV-1 o, Resource-limited Settings: A Multicentre Randomized Phase 3 Clinical Trial
To assess the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing breastfeeding.
Read the detailed description
The prevention of MTCT during pregnancy and through breastfeeding exposure remains challenging to date in most resource-limited settings. Peripartum HIV transmission is already amenable to ARV interventions. These ARV regimens, partially efficacious are insufficiently used despite their apparent simplicity. The postnatal transmission via breastfeeding remains a serious additional threat.
This is a multicentric, non-inferiority, randomized controlled trial aiming at assessing the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women (in Cote d'Ivoire an in Zambia) to prevent MTCT overall in breastfeeding population.
The fixed-dose combination of Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV or Atripla®) is a highly effective HAART combination and the simplest ARV regimen currently available in resource-limited settings and is therefore likely to become soon the lead first-line HAART regimen for adults in such settings. Its anticipated widespread prescription in women of childbearing age requires the proper documentation of its use in pregnancy and during breastfeeding.
The combination of ZDV/3TC (Combivir®) and Lopinavir/ritonavir (LPV/r) (Kaletra® or Aluvia®) is chosen as a reference regimen as it is one of the most commonly used first-line HAART for adults and the reference regimen for PMTCT in industrialised settings.
The maternal ARV regimen will be initiated as soon as possible from 20 weeks of gestation until at least the cessation of breastfeeding (with the advice to cease at six months). The decision to stop or continue the maternal ARV regimen after breastfeeding cessation will be based on the baseline maternal CD4 count and the maternal clinical stage at baseline and/or at breastfeeding cessation. A woman with a baseline CD4 <500 cells/ml will always be proposed to continue her treatment after breastfeeding cessation. A woman with a baseline CD4 count >500 will be asked to stop her treatment after breastfeeding cessation unless she has reached the WHO clinical stage IV at that time.
Infants will receive daily Zidovudine syrup from birth during the first week of life, or an updated ARV post-exposure prophylaxis recommended by WHO when women receive HAART.
- Conditions
- HIV Infection, Pregnancy, Breastfeeding, HIV Infections
- Being tested
- Efavirenz-Tenofovir-Emtricitabine, Zidovudine-Lamivudine-Lopinavir/Ritonavir
- Keywords
- HIV, pregnancy, breastfeeding, PMTCT, ARV treatment, treatment naive
- Medical subject headings
- HIV Infections, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efavirenz-Tenofovir-EmtricitabineDrug
Atripla (R) : Efavirenz 600 mg - Tenofovir 300 mg - Emtricitabine 200 mg; Dosage : 1 pill/day
Zidovudine-Lamivudine-Lopinavir/RitonavirDrug
Combivir (R) : Zidovudine 300 mg - Lamivudine 150 mg Dosage : 1 pill twice a day
Kaletra (R) or Aluvia (R) : Lopinavir 200 mg / Ritonavir 50 mg Dosage : 2 or 3 pills twice a day
| Study group | Role | What they receive |
|---|---|---|
| Atripla (R) | Active comparator | Not described Receives: Drug: Efavirenz-Tenofovir-Emtricitabine |
| Combivir (R) + Kaletra (R) or Aluvia (R) | Active comparator | Not described Receives: Drug: Zidovudine-Lamivudine-Lopinavir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative occurence of : -adverse pregnancy outcomes (spontaneous abortion, stillbirth, congenital abnormality requiring surgical correction in children < 1 yr of age); -paediatric HIV infection; -infant mortality
Measured: at 6 and 12 months following delivery/birth
Secondary outcomes (5)
occurence of grade 4 events in treated women, and of grade 3 or 4 events in ARV-exposed infants
Measured: at 6 and 12 months following delivery/birth
frequency of virological failure (>300 copies/mL) and viral resistance profile
Measured: at 6 month and 12 months post-delivery
frequency of premature delivery (<37 weeks) and frequency of low birth weight (<2500 g)
Measured: at delivery/birth
cumulative incidence of paediatric HIV infection
Measured: at 12 months after delivery
tolerability of the ARV combination in treated women
Measured: at 6 and 12 months following delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: faillure to obtain insurance because of refusal from insurance companies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Gilead Sciences, Merck Sharp & Dohme LLC, GlaxoSmithKline, Abbott
- Responsible party
- Sponsor
- Investigators
- Didier K Ekouevi, MD, PhD, Study chair, Programme PACCI Abidjan, Cote d'IvoireFrançois Dabis, MD, PhD, Study chair, Bordeaux 2 University, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936195
- Sponsor's protocol ID
- ANRS 12200 UMA
- Acronym
- UMA
- Status last verified
- Feb 2012
- First submitted
- 8 Jul 2009
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations in Pregnant and Breastfeeding Women to Prevent mother-to Child Transmission of HIV-1 o, Resource-limited Settings: A Multicentre Randomized Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT00936195
- Acronym / sponsor ID
- UMA / ANRS 12200 UMA
- Conditions
- HIV Infection, Pregnancy, Breastfeeding, HIV Infections
- Keywords
- HIV, pregnancy, breastfeeding, PMTCT, ARV treatment, treatment naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: faillure to obtain insurance because of refusal from insurance companies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Gilead Sciences, Merck Sharp & Dohme LLC, GlaxoSmithKline, Abbott
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing breastfeeding.
Detailed description
The prevention of MTCT during pregnancy and through breastfeeding exposure remains challenging to date in most resource-limited settings. Peripartum HIV transmission is already amenable to ARV interventions. These ARV regimens, partially efficacious are insufficiently used despite their apparent simplicity. The postnatal transmission via breastfeeding remains a serious additional threat.
This is a multicentric, non-inferiority, randomized controlled trial aiming at assessing the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women (in Cote d'Ivoire an in Zambia) to prevent MTCT overall in breastfeeding population.
The fixed-dose combination of Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV or Atripla®) is a highly effective HAART combination and the simplest ARV regimen currently available in resource-limited settings and is therefore likely to become soon the lead first-line HAART regimen for adults in such settings. Its anticipated widespread prescription in women of childbearing age requires the proper documentation of its use in pregnancy and during breastfeeding.
The combination of ZDV/3TC (Combivir®) and Lopinavir/ritonavir (LPV/r) (Kaletra® or Aluvia®) is chosen as a reference regimen as it is one of the most commonly used first-line HAART for adults and the reference regimen for PMTCT in industrialised settings.
The maternal ARV regimen will be initiated as soon as possible from 20 weeks of gestation until at least the cessation of breastfeeding (with the advice to cease at six months). The decision to stop or continue the maternal ARV regimen after breastfeeding cessation will be based on the baseline maternal CD4 count and the maternal clinical stage at baseline and/or at breastfeeding cessation. A woman with a baseline CD4 <500 cells/ml will always be proposed to continue her treatment after breastfeeding cessation. A woman with a baseline CD4 count >500 will be asked to stop her treatment after breastfeeding cessation unless she has reached the WHO clinical stage IV at that time.
Infants will receive daily Zidovudine syrup from birth during the first week of life, or an updated ARV post-exposure prophylaxis recommended by WHO when women receive HAART.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atripla (R) | Active comparator | Drug: Efavirenz-Tenofovir-Emtricitabine |
| Combivir (R) + Kaletra (R) or Aluvia (R) | Active comparator | Drug: Zidovudine-Lamivudine-Lopinavir/Ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- being pregnant, presenting in at least the 20th week of pregnancy and no later than 2 weeks before the expected term;
- at least 18 years of age;
- diagnosed as infected with HIV-1 only;
- not currently taking any ARV drugs;
- having not been exposed to NVP in the 6 months preceding enrolment;
Key exclusion criteria (9 listed)
- presenting within 2 weeks before the expected term;
- currently taking ARV drugs;
- having been exposed to NVP in the 6 months preceding enrolment;
- not willing to breastfeed their forthcoming child;
- having severe renal insufficiency (creatin clearance < 60ml/min);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efavirenz-Tenofovir-EmtricitabineAtripla (R) : Efavirenz 600 mg - Tenofovir 300 mg - Emtricitabine 200 mg; Dosage : 1 pill/day | Drug | Atripla (R) |
| Zidovudine-Lamivudine-Lopinavir/RitonavirCombivir (R) : Zidovudine 300 mg - Lamivudine 150 mg Dosage : 1 pill twice a day Kaletra (R) or Aluvia (R) : Lopinavir 200 mg / Ritonavir 50 mg Dosage : 2 or 3 pills twice a day | Drug | Combivir (R) + Kaletra (R) or Aluvia (R) |
Primary outcome
cumulative occurence of : -adverse pregnancy outcomes (spontaneous abortion, stillbirth, congenital abnormality requiring surgical correction in children < 1 yr of age); -paediatric HIV infection; -infant mortality
Time frame: at 6 and 12 months following delivery/birth
5 secondary outcomes
occurence of grade 4 events in treated women, and of grade 3 or 4 events in ARV-exposed infants
Time frame: at 6 and 12 months following delivery/birth
frequency of virological failure (>300 copies/mL) and viral resistance profile
Time frame: at 6 month and 12 months post-delivery
frequency of premature delivery (<37 weeks) and frequency of low birth weight (<2500 g)
Time frame: at delivery/birth
cumulative incidence of paediatric HIV infection
Time frame: at 12 months after delivery
tolerability of the ARV combination in treated women
Time frame: at 6 and 12 months following delivery/birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier K Ekouevi, MD, PhD study chair
Programme PACCI Abidjan, Cote d'Ivoire
François Dabis, MD, PhD study chair
Bordeaux 2 University, France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efavirenz-Tenofovir-Emtricitabine and Zidovudine-Lamivudine-Lopinavir/Ritonavir in people with HIV Infection and Pregnancy, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 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 10 inclusion and 9 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: withdrawn, as of the sponsor's last update on 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Côte d’Ivoire, Zambia. 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 was withdrawn before enrolling participants, so there are no results.
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?
cumulative occurence of : -adverse pregnancy outcomes (spontaneous abortion, stillbirth, congenital abnormality requiring surgical correction in children < 1 yr of age); -paediatric HIV infection; -infant mortality (time frame: at 6 and 12 months following delivery/birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2012.