IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients (IntensVIH)
This study has been completed.
Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators:
Merck Sharp & Dohme Corp.
Abbott
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier:
NCT00935480
First received: July 8, 2009
Last updated: April 16, 2014
Last verified: April 2014
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Purpose
To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r).
To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by:
- residual plasma replication between 0 and 50 copies/ml
- intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL).
- proviral HIV DNA levels in PBMC and RL.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Isentress® Drug: Celsentri® |
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: | IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
Primary Outcome Measures:
- residual plasma replication between 0 and 50 copies/ml [ Time Frame: one year ] [ Designated as safety issue: No ]
- intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL [ Time Frame: one year ] [ Designated as safety issue: No ]
- proviral HIV DNA levels in PBMC and RL [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CD4 counts [ Time Frame: one year ] [ Designated as safety issue: No ]
- CD8 activation levels [ Time Frame: one year ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | July 2010 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: HAART+Raltegravir 12 months (+/-) Maraviroc |
Drug: Isentress®
P.O, 1 tablet containing 400 mg every 12 hours
Drug: Celsentri®
p.o.: 1 tablet containing 150 mg morning and evening (due to combination with PI/r) or containing 300 mg if fosamprenavir/r is used as the PI (MA)
|
| No Intervention: HAART |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients, aged over 18 years
- HIV infection confirmed by Western Blot
- Karnofsky score > 80%
- Treatment-experienced patients having received combined antiretroviral therapy including at least 2 RTI and 1 PI/r for at least 12 months with plasma viral load <50 copies/ml for at least 6 months
- Stable first-line treatment (or other, if changes were not made for reasons relating to viral resistance) with 2 RTIs and 1 PI/r
- Proper safety and compliance for the ongoing combination;
- Patient agreeing to undergo 3 proctosigmoidoscopy examinations over a 12-month period;
- Plasma HIV-1 RNA <50 copies/ml at inclusion;
- Circulating CD4 >200/mm3 at inclusion;
- Isentress® and Celsentri®-naïve patients
- No contraindications to the use of the investigational products
- Written, informed consent, obtained from the patient or his/her legal representative.
Exclusion Criteria:
- Opportunistic infection or active tumor disease
- Chronic diarrhea, malabsorption, progressive enteric infection
- Aged under 18 years
- Pregnancy - breast-feeding ( a pregnancy test will be done at the inclusion visit)
- Co-infection with HIV-2
- History of immunomodulator treatment (interleukin-2, alpha-interferon)
- Ongoing treatment of HBV or HCV co-infection
- Blood constitution disorders
- Contraindications to the administration of raltegravir or maraviroc
- Circulating CD4 nadir <100/mm3 in the natural history of HIV-1 infection.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00935480
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935480
Locations
| France | |
| Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie | |
| Toulon, France, 83056 | |
| Centre Hospitalier Intercommunal de Toulon La Seyne sur mer | |
| Toulon, France, 83500 | |
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Merck Sharp & Dohme Corp.
Abbott
More Information
| Responsible Party: | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer |
| ClinicalTrials.gov Identifier: | NCT00935480 History of Changes |
| Other Study ID Numbers: | CH-2009.01 |
| Study First Received: | July 8, 2009 |
| Last Updated: | April 16, 2014 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
|
HIV INTEGRASE INHIBITOR Inhibitor on the lymphoid reservoir Residual HIV replication treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Integrase Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016