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AzTrials

HIV InfectionsPhase 2/3ANRS 140 DREAMNCT00946595

Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients

A Phase 2/3 study testing efavirenz/emtricitabin/tenofovir and lopinavir/ritonavir in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site 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

A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (EFV/FTC/TDF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
efavirenz/emtricitabin/tenofovir and lopinavir/ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
1 siteFrance
Study dates
Nov 2009to Jan 2014
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed HIV-1 infection
  • Stable antiretroviral treatment over 6 months
  • HIV-1 RNA < 50 cp/mL for at least 12 months
  • Lymphocytes CD4+ > 200/mm3
  • Lymphocytes CD4+ nadir > 100/mm3
  • Absence of prior treatment failure (defined by two successive HIV-1 RNA ≥ 50 cp/mL under NNRTI or PI treatment)
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  • Absence of documentation of a mutation conferring NRTI or NNRTI resistance or a primary mutation in the protease gene
  • Written informed consent
  • Patient affiliated to a social security scheme

Who cannot join

  • Woman of child bearing potential without efficient contraception
  • Pregnant or breastfeeding woman
  • HBV infection (HbS Ag+)
  • HBC infection requiring specific treatment during the trial
  • Liver cirrhosis Child-Pugh C
  • HIV-1/HIV-2 Co-infection or isolated HIV-2 infection
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  • Ongoing interleukin or interferon treatment
  • Co-administration of contraindicated treatments
  • Hypersensibility to efavirenz or lopinavir/r
  • Absolute neutrophil count < 750/mm3, hemoglobin < 8g/dL, platelets < 60.000/mm3, creatinine clearance < 50 mL/min, ASAT, ALAT, lipase, alkaline phosphatase or total bilirubin > 3 ULN, CD4 nadir < 100/mm3.
  • Participation in another clinical trial interfering with the study drug assignment in DREAM
  • Subject under legal guardianship or incapacitation

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service des maladies infectieuses et tropicales Hopital Saint-Antoine

    Paris, 72012

Other trials in France

About this study

Official title: A Study Comparing Efficacy and Tolerance of Two Maintenance Strategies : a Monotherapy With Lopinavir/Ritonavir or a Single-tablet Triple Therapy by Efavirenz/Emtricitabin/Tenofovir in HIV-1 Infected Patients With HIV RNA Below 50 cp/mL

A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (EFV/FTC/TDF).

Read the detailed description

Today, one of the challenges of HIV treatment is to overcome side effects and toxicity of long term antiretroviral therapy. A promising approach may be the simplification of treatment maintenance strategies, sparing certain antiretroviral drug classes. This is a two-year prospective phase II/III, multicenter randomized trial to evaluate the efficacy and tolerance of a lopinavir/ritonavir monotherapy as a maintenance regimen in HIV-infected adults. Enrolled patients must have had stable antiretroviral treatment and HIV-1 RNA below 50 cp/mL over the previous 12 months, and no prior treatment failure. Provided informed consent, 420 patients are randomized in a 1:1 ratio to two open-label treatment groups and receive either lopinavir/r 800/200mg per day or EFV/FTC/TDF 600/200/245 mg per day (fixed dose combination). The main objective is to assess treatment efficacy and tolerance after 2 years. In 80 patients, repeated DEXA measurements are performed during the trial in order to evaluate changes in bone mineral density and in body composition.

Conditions
HIV Infections
Being tested
efavirenz/emtricitabin/tenofovir, lopinavir/ritonavir
Keywords
Undetectable, HIV infections, Monotherapy, Lopinavir/ritonavir, Protease inhibitor, Treatment experienced
Medical subject headings
HIV Infections

What participants receive

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

  • efavirenz/emtricitabin/tenofovirDrug

    Also called Atripla

    1x600/200/245 mg per day (one tablet) between W0 et W98

  • lopinavir/ritonavirDrug

    Also called Kaletra

    4 x 200/50 mg (4 tablets) once a day between W0 and W98

Study groups in NCT00946595
Study groupRoleWhat they receive
efavirenz/emtricitabin/tenofovirActive comparatorNot described
Receives: Drug: efavirenz/emtricitabin/tenofovir
lopinavir/ritonavirExperimentalNot described
Receives: Drug: lopinavir/ritonavir

What is being measured

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

  1. Proportion of patients without treatment failure at Week 96

    Measured: Week 96

Secondary outcomes (14)

  1. Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at all time points during the trial

    Measured: From Week 0 to Week 96

  2. Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96

    Measured: Week 96

  3. Proportion of patients with plasma HIV-1 RNA below 400 cp/mL at all time points during the trial

    Measured: From Week 0 to Week 96

  4. Evolution of CD4 cell count between Week 0 and Week 96

    Measured: Between Week 0 and Week 96

  5. Evaluation of treatment adherence

    Measured: From Week 0 to Week 96

  6. Evaluation of treatment tolerance

    Measured: From Week 0 to Week 96

  7. Number and type of new resistance mutations in case of two successive plasma HIV-1 RNA ≥ 400 cp/mL

    Measured: From Week 0 to Week 96

  8. Proportion of patients with loss of future drug options

    Measured: From Week 0 to Week 96

  9. Evaluation of quality of life assessments

    Measured: From Week 0 to Week 96

  10. Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, without interference in daily functioning or functioning complaint between Week 0 and Week 96

    Measured: Between Week 0 and Week 96

  11. Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, with interference in daily functioning or functioning complaint between Week 0 and Week 96

    Measured: Between Week 0 and Week 96

  12. Evolution of densitometric parameters between Week 0 and Week 96 in 80 patients

    Measured: Between Week 0 and Week 96

  13. Analysis of the determinants of the durability of the virological response

    Measured: From Week 0 to Week 96

  14. Assessment of pharmacokinetic and pharmacodynamic parameters in both groups if relevant

    Measured: From Week 0 to Week 96

Timeline

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

  1. First posted27 Jul 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJul 2013
  4. Study completionJan 2014

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
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00946595
Sponsor's protocol ID
2009-009776-13
Other IDs
ANRS 140 DREAM, 2009
Acronym
ANRS 140 DREAM
Status last verified
Jun 2014
First submitted
24 Jul 2009
Last updated
24 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Garay OU, Nishimwe ML, Bousmah MA, Janah A, Girard PM, Chene G, Moinot L, Sagaon-Teyssier L, Meynard JL, Spire B, Boyer S. Cost-Effectiveness Analysis of Lopinavir/Ritonavir Monotherapy Versus Standard Combination Antiretroviral Therapy in HIV-1 Infected Patients with Viral Suppression in France (ANRS 140 DREAM). Pharmacoecon Open. 2019 Dec;3(4):505-515. doi: 10.1007/s41669-019-0130-7.

    PubMed 30968368

  • Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.

    PubMed 29767684

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing efavirenz/emtricitabin/tenofovir and lopinavir/ritonavir in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site 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 9 inclusion and 12 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Proportion of patients without treatment failure at Week 96 (time frame: Week 96). 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 NCT00946595, 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 24 Jun 2014.

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