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HIV InfectionsPhase 2ANRS139 TRIONCT00460382

Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses

A Phase 2 study testing raltegravir potassium, darunavir/ritonavir and etravirine 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

The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. 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?
raltegravir potassium, darunavir/ritonavir and etravirine
Type of treatment
Pill or oral medicine
How many people
103 participants
Where
1 siteFrance
Study dates
May 2007to Sep 2009
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 years and above
  • Documented HIV-1 infection.
  • History of virological failure on NNRTIs (patients with a history of toxicity to nevirapine and efavirenz may be enrolled in this study).
  • On a combination antiretroviral therapy for at least 8 weeks prior to the screening visit (if on tipranavir, or enfuvirtide these drugs should have been introduced more than 8 weeks before the screening visit).
  • Patient naive to darunavir, etravirine and to integrase inhibitors
  • Plasma viral load at screening visit over 1000 copies/ml, (no CD4 restriction).
Show all 9Show fewer
  • Genotypic resistance testing at the screening visit:
  • Protease inhibitor mutations: over or equal to 3 primary protease inhibitor mutations among: D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54M, L76V, V82A/F/L/T/S, I84V, N88S and L90M (IAS list 2006) but below or equal to 3 mutations among the following: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, L76V, I84V et L89V (virus sensitivity to darunavir/ritonavir).
  • Reverse transcriptase mutations: over or equal to 3 NRTI mutations (among IAS list) and below or equal to 3 mutations among: A98G, L100I, K101Q/P/E, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179D/E/F/G/I, Y181C/I/V/C/H/L, Y188C/H/L, G190A/C/E/Q/S, P225H, F227C/L, M230I/L, P236L, K238N/T and Y318F (virus sensitivity to etravirine)

Who cannot join

  • Non effective barrier contraception in women of child bearing potential
  • Pregnant women or women who are breastfeeding
  • Opportunistic infection at the acute phase
  • Decompensated cirrhosis (stage B or C of Child-Pugh score)
  • Malignancy requiring chemotherapy or radiotherapy
  • Contraindicated medications being taken by the patient (listed in protocol)
Show all 9Show fewer
  • Allergy to the active substances and expedients of darunavir, etravirine and raltegravir.
  • Haemoglobin < 7g/dl, neutrophil cell count < 500/mm3, platelets < 50,000/mm3, creatinine clearance < 50 ml/mn, P. alkaline, AST, ALT or total bilirubin over or equal to 3 times normal values.
  • Patients receiving experimental agents with an exclusion period for participation in other studies applicable at the screening visit of the current study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Gustave Dron, Service Maladies Infectieuses

    Tourcoing, 59208

Other trials in France

About this study

Official title: Prospective Clinical Trial to Assess Safety and Efficacy of DRV/r(TMC 114/r), ETV(TMC 125) and MK-0518 in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO

The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.

Read the detailed description

Methods: A phase II pilot, prospective, open label, single arm multicentric clinical trial assessing a darunavir/ritonavir, etravirine and MK-0518-containing regimen, if possible associated to an optimized background regimen that may include NRTIs and enfuvirtide, in HIV-1 infected patients failing combination antiretroviral therapy with multi-resistant viruses.

Treatment strategy: Patients will receive raltegravir (MK-0518), darunavir/ritonavir (TMC114/r) and etravirine (TMC125) and if possible an optimized background therapy.

  • raltegravir (MK-0518) (400 mg x 2/d = one 400 mg pill twice daily)
  • darunavir (600 mg x 2/d= two 300 mg pills twice daily with meal)
  • ritonavir (100 mg x 2/d = one 100 mg pill twice daily with meal)
  • etravirine (200 mg x 2/d = two 100 mg pills twice daily with meal)
  • if possible an optimized background therapy: may include NRTI(s) and enfuvirtide but not nonnucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). NRTIs choice is left to the clinician's discretion. Enfuvirtide is highly recommended in enfuvirtide-naive patients but is left to the clinician.

Main outcome: proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at W24.

Secondary outcomes: proportions of patients with HIV RNA levels of less than 50 copies/ml at week 48, with HIV RNA levels of less than 400 copies/ml at week 24 and 48; HIV RNA level evolution between baseline and week 48; HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48; number and type of resistance mutations in case of virologic failure occurrence; CD4 lymphocyte count and proportion evolution between baseline and week 48; HIV infection progression; frequency of the study regimen modifications and interruption; study regimen tolerance; study regimen adherence; association between study drugs' minimum concentrations at week 4 and virologic success at week 24; evolution of pharmacokinetic parameters of study drugs between week 1 and week 4 in the Pharmacokinetic substudy.

Sample size: 103 patients

Enrollment period: 24 weeks

Patient's participation duration: 52 weeks

An extended follow-up (from week 52 to week 96) has been added in April 2008.

Conditions
HIV Infections
Being tested
raltegravir potassium, darunavir/ritonavir, etravirine, Optimized background regimen
Keywords
HIV infections, HIV integrase inhibitor, etravirine, darunavir, MK 0518, raltegravir, Treatment Experienced, Antiviral drug resistance
Medical subject headings
HIV Infections

What participants receive

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

  • raltegravir potassiumDrug

    Also called Isentress

    400 mg twice a day

  • darunavir/ritonavirDrug

    Also called Prezista

    2 pills of 300 mg twice a day

  • etravirineDrug

    Also called TMC125

    2 pills of 100 mg twice a day

  • Optimized background regimenDrug

    Also called OBT, enfuvirtide

    NRTIs and or enfuvirtide (investigator choice)

What is being measured

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

  1. Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24

    Measured: week 24

Secondary outcomes (11)

  1. Proportions of patients with HIV RNA levels of less than 50 copies/ml at week 48, with HIV RNA levels of less than 400 copies/ml at weeks 24 and 48

    Measured: week 24 and 48

  2. HIV RNA level evolution between baseline and week 48

    Measured: from week 0 to 48

  3. HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48

    Measured: from week 0 to 48

  4. Number and type of resistance mutations in case of virologic failure occurrence

    Measured: from week 0 to 48

  5. CD4 lymphocyte count and proportion evolution between baseline and week 48

    Measured: from week 0 to 48

  6. HIV infection progression

    Measured: from week 0 to 48

  7. Frequency of the study regimen modifications and interruption

    Measured: from week 0 to 48

  8. Study regimen tolerance

    Measured: from week 0 to 48

  9. Study regimen adherence

    Measured: from week 0 to 48

  10. Association between study drugs' minimum concentrations at week 4 and week 12 and virologic success at week 24

    Measured: from week 4 to 24

  11. Evolution of pharmacokinetics parameters of study drugs in the PK substudy

    Measured: betwwen week 1 and 4

Timeline

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

  1. First posted13 Apr 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMar 2008
  4. Study completionSep 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00460382
Sponsor's protocol ID
2007-000670-23
Other IDs
ANRS 139 TRIO
Acronym
ANRS139 TRIO
Status last verified
Sep 2010
First submitted
12 Apr 2007
Last updated
17 Sep 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing raltegravir potassium, darunavir/ritonavir and etravirine 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 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: finished, as of the sponsor's last update on 17 Sep 2010. 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 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?

Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24 (time frame: week 24). 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 NCT00460382.

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 17 Sep 2010.

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