Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01033760 |
Recruitment Status
:
Completed
First Posted
: December 16, 2009
Last Update Posted
: February 5, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-1 Infections | Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine Drug: darunavir; ritonavir; emtricitabine/tenofovir | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM) |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: arm 1
darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
|
Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine
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.
|
Active Comparator: arm 2
darunavir, ritonavir, emtricitabine/tenofovir
|
Drug: darunavir; ritonavir; emtricitabine/tenofovir
darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
|
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033760
France | |
Hôpital Gustave Dron | |
Tourcoing, France, 59208 |
Principal Investigator: | Antoine CHERET, PH | Tourcoing Hospital | |
Principal Investigator: | Caroline LASCOUX-COMBE, PH | Saint Louis Hospital, Paris | |
Study Chair: | Laurence MEYER, Professor | Methodologist, INSERM U1018 | |
Principal Investigator: | Bruno HOEN, Professor | Saint Jacques Hospital, CHU Besançon | |
Principal Investigator: | Isabelle RAVAUX, PH | Conception Hospital, Marseille | |
Principal Investigator: | Christine ROUZIOUX, Professor | Virology Investigator, Necker Hospital Paris | |
Principal Investigator: | Alain VENET, PH | Immunology Investigator, INSERM U1012 Bicêtre | |
Principal Investigator: | Daniel OLIVE, Professor | Immunology Investigator, Cancerology Institut Marseille | |
Principal Investigator: | Gianfranco PANCINO, PH | Immunology Investigator, Pasteur Institut Paris | |
Principal Investigator: | Brigitte AUTRAN, Professor | Immunology Investiigator, INSERM U543 Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
ClinicalTrials.gov Identifier: | NCT01033760 History of Changes |
Other Study ID Numbers: |
2009-014742-28 EudraCT ( Registry Identifier: 2009-014742-28 ) |
First Posted: | December 16, 2009 Key Record Dates |
Last Update Posted: | February 5, 2014 |
Last Verified: | February 2014 |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary HIV-1 infection antiretroviral treatment HIV reservoirs |
HIV-DNA levels randomized Treatment Naive |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Darunavir Tenofovir Raltegravir Potassium |
Emtricitabine Maraviroc Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |