Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections AIDS |
Drug: enfuvirtide Drug: emtricitabine/tenofovir disoproxil fumarate Drug: efavirenz or lopinavir/r |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression : ANRS 130 APOLLO |
- Immunological success defined as a CD4 cell count above 200 cells per mm3 after 24 weeks of initial antiretroviral treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 195 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
lopinavir/ritonavir or efavirenz and emtricitabine tenofovir and intensification with enfuvirtide (week 0 to 24)
|
Drug: enfuvirtide
from week 0 to 24
Other Name: Fuzeon
Drug: emtricitabine/tenofovir disoproxil fumarate
1 pill/day
Other Name: Truvada
Drug: efavirenz or lopinavir/r
investigator choice
Other Name: Kaletra, Sustiva
|
|
Active Comparator: 2
lopinavir/ritonavir or efavirenz and emtricitabine/tenofovir
|
Drug: emtricitabine/tenofovir disoproxil fumarate
1 pill/day
Other Name: Truvada
Drug: efavirenz or lopinavir/r
investigator choice
Other Name: Kaletra, Sustiva
|
Detailed Description:
The purpose of this randomized, open-label study is to evaluate the immunological efficacy of two first-line strategies of antiretroviral therapy:
- emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r) intensified by enfuvirtide during the first 24 weeks of therapy.
- emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r)
Patients with CD4 cell 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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, PNN below 750 per mm3, thrombocytopenia below 50000 per mm3, creatinine clearance below 60 ml per min, LFT over 3 ULN
Contacts and Locations| France | |
| Service des Maladies Infectieuses A Hôpital Bichat-Claude Bernard | |
| Paris, France, 75018 | |
| Principal Investigator: | Veronique Joly, MD | Hopital Bichat Claude Bernard Paris France |
| Study Director: | Geneviève Chêne, MD PHD | INSERM U897 Bordeaux France |
More Information
Additional Information:
No publications provided
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00302822 History of Changes |
| Other Study ID Numbers: | 2005-004722-12, ANRS 130 APOLLO |
| Study First Received: | March 14, 2006 |
| Last Updated: | December 21, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV infections Fuzeon Truvada AIDS Treatment Naive |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Enfuvirtide Tenofovir Tenofovir disoproxil Efavirenz |
Lopinavir Emtricitabine HIV Fusion Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013