Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients

NCT01605890 | Completed Phase 2 Results DMC

• 2 other identifiers: ANRS 159 VIH-22011-005038-20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same sensitivity to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment is limited. The first line optimal treatment has to be defined by a prospective and randomized evaluation of other strategies. The primary endpoint will be adapted to the specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to the classical triple therapy, shows an immunovirological response, at least, as good as the one obtained with the triple therapy. The hypothesis is that the low ART response observed in HIV-2 infection is due to a low virological strength of the ARTs used and that the combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at week 48.

Conditions

HIV-2 Infection

Keywords

HIV-2

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in Therapeutic Success

  The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events: * Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks, * CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0, * Raltegravir permanent discontinuation, * Death from any cause, * New B or C events confirmed by an endpoint review committee

  at Week 48

Secondary Outcomes (11)

• Median Change in CD4 Lymphocytes Count at Week 12

  between Week 0 and Week 12

• Number of Clinical and Biological Events

  from Week 0 to Week 48

• Median Change of CD4 Lymphocytes at Week 48

  between Week 0 and Week 48

• Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL

  between Week 0 and Week 48

• Number of Participants With Clinical Progression

  from Week 0 to Week 48

Study Arms (1)

raltegravir / emtricitabine / tenofovir disoproxil fumarate

EXPERIMENTAL

Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .

Interventions

emtricitabine / tenofovir disoproxil fumarate / raltegravir . DRUG

emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

raltegravir / emtricitabine / tenofovir disoproxil fumarate

Eligibility Criteria

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

You may qualify if:

• age ≥18 years
• HIV-2 mono infection, confirmed by ELISA and Western Blot test or Immunoblot,
• antiretroviral treatment-naive, whatever the duration and indication of prior treatments,
• indication to treatment, with at least one of the following criteria : type B or C events, CD4 lymphocytes count below 500/mm3 at screening-visit or CD4 lymphocytes count decrease of at least 50 cell/µL/year over the last 3 years with the last CD4 lymphocytes count within -/+ 10 % of the nadir, plasma HIV-2 RNA load over or equal to 100 copies/mL at screening-visit,
• Pneumocystis prophylaxis if CD4 lymphocytes count below 200/mm3, combined to a toxoplasmosis prophylaxis in case of a positive toxoplasmosis serology,
• French residency for at least one year,
• Written informed consent, signed by the participant and the investigator (at the latest on the screening-visit and prior any study related intervention)
• Affiliate or beneficiary of a social security system (State Medical Assistance is not a social security scheme).

You may not qualify if:

• Absence of effective contraception method(women),
• Pregnancy, breastfeeding or wish for pregnancy during the trial,
• Curative treatment of a progressive opportunistic infection not compatible with those evaluated in the present study,
• Malignant or tumorous affection requiring chemotherapy or radiotherapy,
• Decompensated cirrhosis,
• Viral hepatitis C with a Metavir score over F2,
• Hemoglobinemia below 7g/dL, polynuclear neutrophils below 500/mm3, platelets below 50 000/mm3, creatinine clearance below 50 mL/mn, transaminase, alkaline phosphatase or bilirubin over 2.5N,
• Contraindication to one of the excipients of study treatments,
• Insuline-dependent diabetes mellitus not well controlled (with glycated haemoglobin (HbA1C) over 7%),
• Long-term corticosteroid treatment (more than 3 weeks of treatment),
• Judicial protection, legal guardianship,

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Gilead Sciences: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Related Publications (1)

• Matheron S, Descamps D, Gallien S, Besseghir A, Sellier P, Blum L, Mortier E, Charpentier C, Tubiana R, Damond F, Peytavin G, Ponscarme D, Collin F, Brun-Vezinet F, Chene G; France REcherche Nord&Sud Sida-Hiv Hepatites (ANRS) 159 HIV-2 Trial Study Group. First-line Raltegravir/Emtricitabine/Tenofovir Combination in Human Immunodeficiency Virus Type 2 (HIV-2) Infection: A Phase 2, Noncomparative Trial (ANRS 159 HIV-2). Clin Infect Dis. 2018 Sep 28;67(8):1161-1167. doi: 10.1093/cid/ciy245.

  PMID: 29590335 DERIVED

MeSH Terms

Interventions

Emtricitabine; Tenofovir; Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrrolidinones; Pyrrolidines

Results Point of Contact

• Title: Pr Sophie Matheron
• Organization: Hopital Bichat-Claude Bernard, AP-HP, Paris, France

sophie.matheron@aphp.fr

+33140257883

Study Officials

• Sophie Matheron, Pr

  Hopital Bichat-Claude Bernard

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 25, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 2, 2026
• Results First Posted: July 20, 2018

Record last verified: 2026-04

Locations

FR (1)