HIV-2 InfectionPhase 2VIH-2NCT01605890
Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
A Phase 2 study testing emtricitabine / tenofovir disoproxil fumarate / raltegravir . in people with HIV-2 Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-2 Infection
- What is being tested?
- emtricitabine / tenofovir disoproxil fumarate / raltegravir .
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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).
Who cannot join
- 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,
Show all 12Show fewer
- 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,
- Participation in other therapeutic trial or comprising an exclusion period ongoing at the time of the screening-visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
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
- Being tested
- emtricitabine / tenofovir disoproxil fumarate / raltegravir .
- Keywords
- HIV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| raltegravir / emtricitabine / tenofovir disoproxil fumarate | Experimental | Not described Receives: Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at Week 48
Secondary outcomes (11)
Median Change in CD4 Lymphocytes Count at Week 12
Measured: between Week 0 and Week 12
Number of Clinical and Biological Events
Measured: from Week 0 to Week 48
Median Change of CD4 Lymphocytes at Week 48
Measured: between Week 0 and Week 48
Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
Measured: between Week 0 and Week 48
Number of Participants With Clinical Progression
Clinical progression is defined as the switch:
- from category A to B, C or death.
- from category B to C or death.
Measured: from Week 0 to Week 48
Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence
Measured: from Week 4 to Week 48
Number of Virological Failure Participants With Resistance Mutations
Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported.
Measured: from Week 0 to Week 48
Number of Participants With Treatment Switch or Discontinuation
Overall (regardless of the molecule)
Measured: from Week 0 to Week 48
Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48
Measured: at Week 48
Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire
The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:
Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated.
Measured: from Week 0 to Week 48
Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-2 InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Gilead Sciences, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Sophie Matheron, Pr, Study chair, Hopital Bichat-Claude Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605890
- Sponsor's protocol ID
- ANRS 159 VIH-2
- Other IDs
- 2011-005038-20
- Acronym
- VIH-2
- Status last verified
- Apr 2026
- First submitted
- 22 May 2012
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29590335
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
- ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
- ClinicalTrials.gov ID
- NCT01605890
- Acronym / sponsor ID
- VIH-2 / ANRS 159 VIH-2
- Conditions
- HIV-2 Infection
- Keywords
- HIV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Gilead Sciences, Merck Sharp & Dohme LLC
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 20 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| raltegravir / emtricitabine / tenofovir disoproxil fumarate | Experimental | Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
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 |
|---|---|---|
| emtricitabine / tenofovir disoproxil fumarate / raltegravir .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. | Drug | raltegravir / emtricitabine / tenofovir disoproxil fumarate |
Primary outcome
Percentage of Participants in Therapeutic Success
Time frame: at Week 48
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
11 secondary outcomes
Median Change in CD4 Lymphocytes Count at Week 12
Time frame: between Week 0 and Week 12
Number of Clinical and Biological Events
Time frame: from Week 0 to Week 48
Median Change of CD4 Lymphocytes at Week 48
Time frame: between Week 0 and Week 48
Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
Time frame: between Week 0 and Week 48
Number of Participants With Clinical Progression
Time frame: from Week 0 to Week 48
Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence
Time frame: from Week 4 to Week 48
Number of Virological Failure Participants With Resistance Mutations
Time frame: from Week 0 to Week 48
Number of Participants With Treatment Switch or Discontinuation
Time frame: from Week 0 to Week 48
Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48
Time frame: at Week 48
Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire
Time frame: from Week 0 to Week 48
Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29590335Matheron 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.
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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.
Sophie Matheron, Pr study chair
Hopital Bichat-Claude Bernard
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 emtricitabine / tenofovir disoproxil fumarate / raltegravir . in people with HIV-2 Infection, 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 8 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: finished, 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?
Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants in Therapeutic Success (time frame: at Week 48). 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 NCT01605890, which also lists 1 linked publication.
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.