IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients

This study has been completed.

Sponsor:

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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

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
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935480

Locations


France
Centre Hospitalier Intercommunal de Toulon La Seyne sur mer
Toulon, France, 83500
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
Toulon, France, 83056

Sponsors and Collaborators

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Merck Sharp & Dohme Corp.

Abbott

More Information

No publications provided


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:


Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions

ClinicalTrials.gov processed this record on March 01, 2015

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