HIV-1 InfectionsPhase 3NCT01033760

Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

A Phase 3 study testing raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine and darunavir; ritonavir; emtricitabine/tenofovir in people with HIV-1 Infections, run by ANRS, Emerging Infectious Diseases 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 trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infections
What is being tested?: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine and darunavir; ritonavir; emtricitabine/tenofovir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteFrance
Study dates: Apr 2010to Dec 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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with acute or primary HIV-1 infection
Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24.
Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and < 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.
Symptomatic Primary infection or CD4 <500/mm3
written informed consent
≥ 18 years old

Who cannot join

Prior post exposure antiretroviral treatment within six months before enrolment
Pregnancy or breast-feeding
HIV-2 infection
Current malignancy
Prothrombin time < 50%
Creatinine clearance < 60 ml/min
ASAT, ALAT or bilirubin ≥10*N
Platelets < 25000/mm3

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpital Gustave Dron
Tourcoing, 59208

Other trials in France

About this study

Official title: Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)

Read the detailed description

Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.

After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).

We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.

Conditions: HIV-1 Infections
Being tested: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine, darunavir; ritonavir; emtricitabine/tenofovir
Keywords: Primary HIV-1 infection, antiretroviral treatment, HIV reservoirs, HIV-DNA levels, randomized, Treatment Naive

What participants receive

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

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabineDrug
raltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
darunavir; ritonavir; emtricitabine/tenofovirDrug
darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.

Study groups in NCT01033760
Study group	Role	What they receive
arm 1	Experimental	darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir Receives: Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine
arm 2	Active comparator	darunavir, ritonavir, emtricitabine/tenofovir Receives: Drug: darunavir; ritonavir; emtricitabine/tenofovir

What is being measured

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

To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection
Measured: 24 months

Secondary outcomes (6)

Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30
Measured: 30 months
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24
Measured: 24 months
Changes in cell-associated HIV-DNA between baseline and M24
Measured: 24 Months
Evolution of the CD4 and CD8 between D0 and M24
Measured: 24 months
Tolerability of trial treatments
Measured: 24 months
Number and type of ARV mutations in virological failures and change in CCR5 tropism
Measured: 24 Months

Timeline

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

Apr 2010Dec 2013

First posted16 Dec 2009 (estimated)
Study startApr 2010
Primary completionJul 2013
Study completionDec 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 HIV-1 InfectionsStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01033760
Sponsor's protocol ID: 2009-014742-28
Other IDs: EudraCT, 2009
Status last verified: Feb 2014
First submitted: 15 Dec 2009
Last updated: 5 Feb 2014
Results posted: No
Data monitoring committee: No

Publications

Cheret A, Durier C, Melard A, Ploquin M, Heitzmann J, Lecuroux C, Avettand-Fenoel V, David L, Pialoux G, Chennebault JM, Muller-Trutwin M, Goujard C, Rouzioux C, Meyer L; ANRS OPTIPRIM study group. Impact of early cART on HIV blood and semen compartments at the time of primary infection. PLoS One. 2017 Jul 14;12(7):e0180191. doi: 10.1371/journal.pone.0180191. eCollection 2017.
PubMed 28708873
Cheret A, Nembot G, Melard A, Lascoux C, Slama L, Miailhes P, Yeni P, Abel S, Avettand-Fenoel V, Venet A, Chaix ML, Molina JM, Katlama C, Goujard C, Tamalet C, Raffi F, Lafeuillade A, Reynes J, Ravaux I, Hoen B, Delfraissy JF, Meyer L, Rouzioux C; OPTIPRIM ANRS Study Group. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015 Apr;15(4):387-96. doi: 10.1016/S1473-3099(15)70021-6. Epub 2015 Feb 18.
PubMed 25701561

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1 Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)
ClinicalTrials.gov ID: NCT01033760
Acronym / sponsor ID: 2009-014742-28
Conditions: HIV-1 Infections
Keywords: Primary HIV-1 infection, antiretroviral treatment, HIV reservoirs, HIV-DNA levels, randomized, Treatment Naive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: ANRS, Emerging Infectious DiseasesOther government
Collaborators: Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer, Janssen-Cilag Ltd.
Study start: Apr 2010
Primary completion: Jul 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 16 Dec 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
arm 1	Experimental	Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabinedarunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
arm 2	Active comparator	Drug: darunavir; ritonavir; emtricitabine/tenofovirdarunavir, ritonavir, emtricitabine/tenofovir

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with acute or primary HIV-1 infection
Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24.
Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and < 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.
Symptomatic Primary infection or CD4 <500/mm3
written informed consent

Key exclusion criteria (8 listed)

Prior post exposure antiretroviral treatment within six months before enrolment
Pregnancy or breast-feeding
HIV-2 infection
Current malignancy
Prothrombin time < 50%

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; maraviroc; darunavir; ritonavir; tenofovir/emtricitabineraltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.	Drug	arm 1
darunavir; ritonavir; emtricitabine/tenofovirdarunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.	Drug	arm 2

Primary outcome

To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection
Time frame: 24 months

6 secondary outcomes

Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30
Time frame: 30 months
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24
Time frame: 24 months
Changes in cell-associated HIV-DNA between baseline and M24
Time frame: 24 Months
Evolution of the CD4 and CD8 between D0 and M24
Time frame: 24 months
Tolerability of trial treatments
Time frame: 24 months
Number and type of ARV mutations in virological failures and change in CCR5 tropism
Time frame: 24 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
Derived from this study: PubMed 28708873Cheret A, Durier C, Melard A, Ploquin M, Heitzmann J, Lecuroux C, Avettand-Fenoel V, David L, Pialoux G, Chennebault JM, Muller-Trutwin M, Goujard C, Rouzioux C, Meyer L; ANRS OPTIPRIM study group. Impact of early cART on HIV blood and semen compartments at the time of primary infection. PLoS One. 2017 Jul 14;12(7):e0180191. doi: 10.1371/journal.pone.0180191. eCollection 2017.
Derived from this study: PubMed 25701561Cheret A, Nembot G, Melard A, Lascoux C, Slama L, Miailhes P, Yeni P, Abel S, Avettand-Fenoel V, Venet A, Chaix ML, Molina JM, Katlama C, Goujard C, Tamalet C, Raffi F, Lafeuillade A, Reynes J, Ravaux I, Hoen B, Delfraissy JF, Meyer L, Rouzioux C; OPTIPRIM ANRS Study Group. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015 Apr;15(4):387-96. doi: 10.1016/S1473-3099(15)70021-6. Epub 2015 Feb 18.

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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.

Antoine CHERET, PH principal investigator

Tourcoing Hospital

Caroline LASCOUX-COMBE, PH principal investigator

Saint Louis Hospital, Paris

Laurence MEYER, Professor study chair

Methodologist, INSERM U1018

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 8 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 5 Feb 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 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 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?

To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection (time frame: 24 months). 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 NCT01033760, 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 5 Feb 2014.