Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136

NCT00421551 | Completed Phase 3 DMC

• 2 other identifiers: 2006-005962-38ANRS 136 MONOI
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.

Conditions

HIV Infections

Keywords

HIV Infections; darunavir; Ritonavir; HIV Protease Inhibitors; treatment experienced

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with virological success, the virological failure is defined as 2 consecutive plasma viral load measurements greater or equal to 400 cp/ml within 2 weeks at W48

  W48

Secondary Outcomes (16)

• Proportion of patients with virological success between W48 and W96,

  W96

• Proportion of patients with HIV-1 RNA below 50 copies/mL, between 50 to 400 copies/mL and > 400 copies/ml from D0 to W96,

  W96

• Time to virologic failure,

  between W0 and W96

• PI genotypic resistance mutations occurring during the follow-up

  between W0 and W96

• Change in proviral DNA at D0, W48 and W96,

  W0, W48 and W96

Study Arms (2)

1

EXPERIMENTAL

Drug: Darunavir; Drug: ritonavir

2

ACTIVE COMPARATOR

Drug: Darunavir; Drug: ritonavir

Interventions

Darunavir DRUG

during the 48 first weeks of the trial, (2x300mg) twice a day between W48 and W96, (2x400mg) once a day

Also known as: Prezista

1; 2

ritonavir DRUG

during the first 48 weeks, 100mg twice a day between W48 and W96, 100mg once a day

Also known as: Norvir

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed HIV-1 infection.
• Documented level of HIV-1 RNA at initiation of antiretroviral treatments
• Prior antiretroviral regimen, including at least 2 NRTIs combined to 1 PI or NNRTI or a third NRTI for at least 18 months prior to study entry.
• CD4 count of 200 cells per mm3 or greater.
• Viral load below 400 copies per ml within 18 months prior to entry and below 50 copies per mL at entry.
• Willing to use acceptable methods of contraception

You may not qualify if:

• Previous virological failure under prior PI-based regimen.
• Prior therapy in the darunavir.
• HIV-2 infected patients.
• Absence of documented level of HIV-1 RNA at initiation of antiretroviral treatments
• Hepatitis B or C infection within 90 days prior to study entry.
• Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
• Serious acute illness requiring systemic treatment or hospitalization in the 14 days prior to study entry.
• Treatment for an active AIDS defining opportunistic infection within 30 days prior to screening
• Drug or alcohol use or any dependence that would interfere with compliance.
• Pregnancy or breastfeeding

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (1)

Service des maladies infectieuses et tropicales Hopital Pitie salpetriere

Paris, 75013, France

Location

Related Publications (3)

• 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.

  PMID: 29767684 DERIVED

• Lambert-Niclot S, Flandre P, Valantin MA, Soulie C, Fourati S, Wirden M, Sayon S, Pakianather S, Bocket L, Masquelier B, Dos Santos G, Katlama C, Calvez V, Marcelin AG. Similar evolution of cellular HIV-1 DNA level in darunavir/ritonavir monotherapy versus triple therapy in MONOI-ANRS136 trial over 96 weeks. PLoS One. 2012;7(7):e41390. doi: 10.1371/journal.pone.0041390. Epub 2012 Jul 25.

  PMID: 22848481 DERIVED

• Katlama C, Valantin MA, Algarte-Genin M, Duvivier C, Lambert-Niclot S, Girard PM, Molina JM, Hoen B, Pakianather S, Peytavin G, Marcelin AG, Flandre P. Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS. 2010 Sep 24;24(15):2365-74. doi: 10.1097/QAD.0b013e32833dec20.

  PMID: 20802297 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Study Officials

• Christine Katlama, MD

  AP-HP hopital Pitié salpetriere Paris

  PRINCIPAL INVESTIGATOR

• Philippe Flandre

  Inserm UMR S720

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 12, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

FR (1)