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HIV patients may ditch one drug without losing viral control

NCT ID NCT02302547

Disease control Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether people with HIV who have a low viral reservoir can safely switch from a three-drug regimen to a two-drug regimen (Truvada alone) while keeping the virus under control. The goal is to reduce long-term side effects and treatment costs. The trial involved 224 participants with well-controlled HIV and looked at viral load after 48 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

224 people

The number who actually took part.

Started

Dec 2014

Finished

Sep 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HIV-1 infected patient * Initial TT ARV started above (or equal to) 150 / mm3 LT CD4, and 18 months prior to inclusion in the study * Ongoing antiretroviral therapy combining tenofovir + emtricitabine + a 3rd agent (IP / r, IP, NNRTI, II, Inhibitors) with at least one undetectable viral load (CV \<50 copies / mL) after introduction of the latter treatment. * Patient in virological success: CV \<50 copies / mL for at least 12 months, including visit to selection. * Absence of previous therapeutic failure: no viral load ≥ 200 copies / mL (after 6 months of treatment) (Except in the case of a justified therapeutic interruption: travel, stock-out ...) and of obtaining success Virologic after introduction of treatment, without concept of genotypic resistance known to the ARVs used. * Cellular DNA-HIV \<2.7 log copies / 106 PBMC * Zenith RNA-HIV \<150,000 copies / ml (excluding viral load values during primary infection if it is documented) * No genotypic resistance to currently used and known ARVs * Patient who has given written informed consent * Affiliate or beneficiary of a social security scheme * Patient followed on an outpatient basis, age ≥ 18 years. Exclusion Criteria: * Non-compliant patient * Subject is pregnant, or lactating, or of childbearing potential and without contraception * Active opportunistic infections * Major overweight (BMI ≥ 40) * Severe renal pathology (creatinine clearance \< 30ml/min) * Cirrhosis or severe liver failure (factor V \< 50%) * Prognosis threatened within 6 months * Circumstances that may impair judgment or understanding of the information given to the patient * Malabsorption syndromes * The following laboratory criteria: * Serum ASAT,ALAT \> 5 x upper limit of normal (ULN) * Thrombocytopenia with platelet count \< 50.000/ml * Anemia with hemoglobin \< 8g/dl * Polynuclear neutrophil count \< 500/mm3

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

Contacts and locations

Locations

  • CHU de NANCY

    Nancy, 54035, France

  • Centre de diagnostic et thérapeutique, Hopital Hotel Dieu

    Paris, 94010, France

  • Consultation Maladies Infectieuses, Chu de Poitiers, Cedex

    Poitiers, 86021, France

  • Hospital Tenon

    Paris, 75970, France

  • Maladies Infectieuses, CHU de ROUEN

    Rouen, 76031, France

  • Médecine Interne, Hôpital FOCH

    Suresnes, 92151, France

  • Service Universitaire des Maladies Infectieuses et du Voyageur, CH DRON

    Tourcoing, 59200, France

  • Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor

    Créteil, 94010, France

  • Service de Medecine Interne et Maladies Infectieuses, CHRU BRETONNEAU, TOURS CEDEX9

    Tours, 37044, France

  • Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01

    La Rochelle, 17019, France

  • Service de Médecine Interne, CH de SAINTONGE- BP 326

    Saintes, 17108, France

  • Service de Pneumologie, centre Hospitalier Fontenoy, CH de CHARTRES

    Le Coudray, 28630, France

  • Service des Maladies Infectieuses et tropicales, APHP SAINT LOUIS

    Paris, 75475, France

  • Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2

    CHR d'ORLEANS, 45067, France

  • Service des maladies Infectieuses et tropicales, CH GEORGES RENON

    Niort, 79021, France

  • Unité des Maladies Infectieuses, CHU de CAEN

    Caen, 14033, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.