Human Immunodeficiency VirusPhase 2ROCnRALNCT01420523
Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy
A Phase 2 study testing Raltegravir-Maraviroc in people with Human Immunodeficiency Virus and Lipohypertrophy, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Lipohypertrophy
- What is being tested?
- Raltegravir-Maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Apr 2013
- 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
- Patients infected with HIV-1 type B or CRF02.
- ≥ 18 years old
- Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months.
- Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and < 50 copies/mL for at least 12 months.
- Patients with an R5* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3
- Patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump).
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- Patients who have never been treated with raltegravir.
- Patients who have never been treated with maraviroc.
- Efficient contraception for women
- Free and informed written consent, signed by the patient and the investigator.
- Patients with health insurance. * To increase the certainty of selecting patients with an R5 virus, the HIV-1 tropism will be determined by the genotype method and interpreted with the Geno2pheno[coreceptor] algorithm and a false positive rate threshold for X4 virus at 20%, rather than the usual 10%.
Who cannot join
- X4, X4/5 or undetermined tropism of the HIV virus.
- HIV-2 or coinfection HIV-1/HIV-2.
- Chronic viral hepatitis B.
- Chronic viral hepatitis C requiring specific treatment over the first 24 weeks.
- Treatment with growth hormones.
- Hypolipemic or diabetes treatment, begun within the last 3 months.
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- Pregnant or breastfeeding women.
- Haemoglobin < 7g/dl, neutrophils < 500/mm3, platelets < 50 000/mm3, creatinine clearance < 50 mL/min, alkaline phosphatases, ASAT, ALAT or bilirubin ≥ 3 times the upper limit of the normal range (N).
- Antiretroviral treatment associated to enzymatic inducer.
- Chronic alcohol consumption.
- Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
- Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Pilot Study Evaluating the Efficacy of Dual Therapy With Raltegravir Plus Maraviroc in Patients Receiving Suppressive Antiretroviral Therapy and Presenting With Lipohypertrophy (ANRS 157 ROCnRAL).
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.
Read the detailed description
Assess the ability to maintain the plasma HIV viral load below the threshold needed for detection (< 50 copies/mL) at 24 weeks of raltegravir/maraviroc therapy without NRTIs and PIs, in patients with virological success and presenting with clinical lipohypertrophy.
- Conditions
- Human Immunodeficiency Virus, Lipohypertrophy
- Being tested
- Raltegravir-Maraviroc
- Keywords
- HIV, Lipohypertrophy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir-MaravirocDrug
Also called Isentress and Celsentri
Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir-Maraviroc | Experimental | Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day Receives: Drug: Raltegravir-Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological failure
Occurrence of virological failure, as verified by 2 consecutive plasma viral load measurements > 50 copies/mL, taken 2 to 4 weeks apart at most, during the first 24 weeks.
Measured: Week 24
Secondary outcomes (4)
Viro-immunological efficacy
- Proportion of patients with a HIV RNA viral load < 50 copies/mL.
- Proportion of patients discontinuing the therapy:
- Plasma genotypic resistance profile where the viral load is > 50 copies/mL.
- Evaluation of DNA/RNA tropism in the event of failure.
- Evaluation of plasma HIV RNA where the viral load is < 50 copies/mL, through ultrasensitive PCR testing.
- Evolution of the CD4 and CD8 T-cell counts.
- Blood concentration of raltegravir and maraviroc.
Measured: Between baseline and W48
Tolerability criteria and metabolic impact
- Changes in glucose and lipid balance.
- Changes in anthropometric measurements.
- Number and severity of clinical and biological adverse effects.
- Changes in bone mineral density and body composition, as measured by DEXA scan.
- Changes in inflammation and endothelial activation markers between baseline and W48
- Measurement of fat cells differentiation markers in adipose tissue biopsy samples
Measured: Between baseline and W48
Compliance
- Assessment of compliance conducted at screening and at W24 and 48.
Measured: Between baseline and W48
Quality of life
- Assessment of health-related quality of life conducted at baseline and at W24 and 48.
Measured: Between baseline and W48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC, ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Christine Katlama, MD, Principal investigator, Groupe hospitalier Pitié-SalpétrièreDominique Costagliola, Study director, Inserm U943
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420523
- Sponsor's protocol ID
- ANRS 157 ROCnRAL
- Other IDs
- 2011-002483-24
- Acronym
- ROCnRAL
- Status last verified
- Apr 2026
- First submitted
- 18 Aug 2011
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Soulie C, Assoumou L, Darty M, Rodriguez C, Donati F, Sayon S, Peytavin G, Valantin MA, Caby F, Schneider L, Canestri A, Costagliola D, Katlama C, Calvez V, Marcelin AG; ROCnRAL ANRS-157 Study Group. Virological factors associated with outcome of dual maraviroc/raltegravir therapy (ANRS-157 trial). J Antimicrob Chemother. 2015 Dec;70(12):3339-44. doi: 10.1093/jac/dkv280. Epub 2015 Sep 22.
PubMed 26396157Katlama C, Assoumou L, Valantin MA, Soulie C, Duvivier C, Chablais L, Kolta S, Pialoux G, Mercie P, Simon A, Costagliola D, Peytavin G, Marcelin AG; ROCnRAL ANRS 157 Study Group. Maraviroc plus raltegravir failed to maintain virological suppression in HIV-infected patients with lipohypertrophy: results from the ROCnRAL ANRS 157 study. J Antimicrob Chemother. 2014 Jun;69(6):1648-52. doi: 10.1093/jac/dkt536. Epub 2014 Feb 16.
PubMed 24535278
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study Evaluating the Efficacy of Dual Therapy With Raltegravir Plus Maraviroc in Patients Receiving Suppressive Antiretroviral Therapy and Presenting With Lipohypertrophy (ANRS 157 ROCnRAL).
- ClinicalTrials.gov ID
- NCT01420523
- Acronym / sponsor ID
- ROCnRAL / ANRS 157 ROCnRAL
- Conditions
- Human Immunodeficiency Virus, Lipohypertrophy
- Keywords
- HIV, Lipohypertrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Merck Sharp & Dohme LLC, ViiV Healthcare
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Aug 2011 (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.
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.
Detailed description
Assess the ability to maintain the plasma HIV viral load below the threshold needed for detection (< 50 copies/mL) at 24 weeks of raltegravir/maraviroc therapy without NRTIs and PIs, in patients with virological success and presenting with clinical lipohypertrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir-Maraviroc | Experimental | Drug: Raltegravir-MaravirocRaltegravir 400 mg twice a day + Maraviroc 300 mg twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients infected with HIV-1 type B or CRF02.
- ≥ 18 years old
- Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months.
- Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and < 50 copies/mL for at least 12 months.
- Patients with an R5* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3
Key exclusion criteria (12 listed)
- X4, X4/5 or undetermined tropism of the HIV virus.
- HIV-2 or coinfection HIV-1/HIV-2.
- Chronic viral hepatitis B.
- Chronic viral hepatitis C requiring specific treatment over the first 24 weeks.
- Treatment with growth hormones.
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 |
|---|---|---|
| Raltegravir-MaravirocAlso: Isentress and CelsentriRaltegravir 400 mg twice a day + Maraviroc 300 mg twice a day | Drug | Raltegravir-Maraviroc |
Primary outcome
Virological failure
Time frame: Week 24
Occurrence of virological failure, as verified by 2 consecutive plasma viral load measurements > 50 copies/mL, taken 2 to 4 weeks apart at most, during the first 24 weeks.
4 secondary outcomes
Viro-immunological efficacy
Time frame: Between baseline and W48
Tolerability criteria and metabolic impact
Time frame: Between baseline and W48
Compliance
Time frame: Between baseline and W48
Quality of life
Time frame: Between baseline and W48
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Derived from this study: PubMed 26396157Soulie C, Assoumou L, Darty M, Rodriguez C, Donati F, Sayon S, Peytavin G, Valantin MA, Caby F, Schneider L, Canestri A, Costagliola D, Katlama C, Calvez V, Marcelin AG; ROCnRAL ANRS-157 Study Group. Virological factors associated with outcome of dual maraviroc/raltegravir therapy (ANRS-157 trial). J Antimicrob Chemother. 2015 Dec;70(12):3339-44. doi: 10.1093/jac/dkv280. Epub 2015 Sep 22.
- Derived from this study: PubMed 24535278Katlama C, Assoumou L, Valantin MA, Soulie C, Duvivier C, Chablais L, Kolta S, Pialoux G, Mercie P, Simon A, Costagliola D, Peytavin G, Marcelin AG; ROCnRAL ANRS 157 Study Group. Maraviroc plus raltegravir failed to maintain virological suppression in HIV-infected patients with lipohypertrophy: results from the ROCnRAL ANRS 157 study. J Antimicrob Chemother. 2014 Jun;69(6):1648-52. doi: 10.1093/jac/dkt536. Epub 2014 Feb 16.
- Related InfoLink provided by the sponsor.
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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.
Christine Katlama, MD principal investigator
Groupe hospitalier Pitié-Salpétrière
Dominique Costagliola study director
Inserm U943
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltegravir-Maraviroc in people with Human Immunodeficiency Virus and Lipohypertrophy, run by ANRS, Emerging Infectious Diseases 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 11 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: stopped early, as of the sponsor's last update on 2 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 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 was stopped early. Results are not available in the source record.
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?
Virological failure (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 NCT01420523, 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 2 Apr 2026.