Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

April 2, 2026 updated by: French National Agency for Research on AIDS and Viral Hepatitis

Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression : ANRS 130 APOLLO

HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity.

The aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment.

We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this randomized, open-label study is to evaluate the immunological efficacy of two first-line strategies of antiretroviral therapy:

  1. emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r) intensified by enfuvirtide during the first 24 weeks of therapy.
  2. emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r)

Patients with lymphocytes T CD4+ cell (CD4)count below 100 per mm3, or CD4 cell count below 200 per mm3 and past history or presence of AIDS defining event and naïve of any antiretroviral therapy will be eligible. This multicenter study will enroll 220 patients (n=110 in each arm). The planned duration of the study is 48 weeks from the enrolment of the last subject.

The primary endpoint will be immunological success defined as CD4 cell count above 200 cells per mm3 after 24 weeks of initial treatment. The durability of this response will be evaluated and patients will be followed for 48 weeks.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Service des Maladies Infectieuses A Hôpital Bichat-Claude Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Antiretroviral naïve HIV-1 infected patients
  • CD4 cell count below 100 per mm3, or CD4 cell count below 200/mm3 and past history or presence of B or C(AIDS defining)event
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy; breast feeding
  • Coinfection with HIV-2 or infection with HIV-1 subtype O
  • Antiretroviral pretreated patients
  • Neoplasia disease currently treated with chemotherapy or radiotherapy
  • Severe liver failure
  • Treatment with cytokines or HIV vaccine trial
  • One or more of the following biological abnormalities: hemoglobin below 10 g/dl, Neutrophils below 750 per mm3, thrombocytopenia below 50000 per mm3, creatinine clearance below 60 ml per min, Liver Function Tests over 3 Upper Limit of Normal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensification
lopinavir or efavirenz and emtricitabine/tenofovir and intensification with enfuvirtide (week 0 to 24)
Drug: enfuvirtide
from week 0 to 24
Other Names:
  • Fuzeon
Drug: emtricitabine/tenofovir
1 pill/day
Other Names:
  • Truvada
Drug: lopinavir or efavirenz
investigator choice
Other Names:
  • Kaletra, Sustiva
Active Comparator: Standard
lopinavir or efavirenz and emtricitabine/tenofovir
Drug: emtricitabine/tenofovir
1 pill/day
Other Names:
  • Truvada
Drug: lopinavir or efavirenz
investigator choice
Other Names:
  • Kaletra, Sustiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunological success defined as a CD4 cell count above 200 cells per mm3 after 24 weeks of initial antiretroviral treatment
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Virological response, clinical progression, tolerance,toxicity, quality of life under therapy, adherence and resistance mutations emerging in case of virological failure.
Time Frame: from 0 to 48 weeks
from 0 to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Gilead Sciences
Hoffmann-La Roche

Investigators

  • Study Director: Geneviève Chêne, MD PHD, INSERM U897 Bordeaux France
  • Principal Investigator: Veronique Joly, MD, Hopital Bichat Claude Bernard Paris France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria

March 14, 2006

First Posted (Estimated)

March 15, 2006

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 130 APOLLO
  • 2005-004722-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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