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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections	Drug: Isentress®; Drug: Celsentri®	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Actual Study Start Date :	October 2010
Actual Primary Completion Date :	November 12, 2010
Actual Study Completion Date :	August 8, 2014

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. residual plasma replication between 0 and 50 copies/ml [ Time Frame: one year ]
2. intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL [ Time Frame: one year ]
3. proviral HIV DNA levels in PBMC and RL [ Time Frame: one year ]

Secondary Outcome Measures :

1. CD4 counts [ Time Frame: one year ]
2. CD8 activation levels [ Time Frame: one year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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:

1. Opportunistic infection or active tumor disease
2. Chronic diarrhea, malabsorption, progressive enteric infection
3. Aged under 18 years
4. Pregnancy - breast-feeding ( a pregnancy test will be done at the inclusion visit)
5. Co-infection with HIV-2
6. History of immunomodulator treatment (interleukin-2, alpha-interferon)
7. Ongoing treatment of HBV or HCV co-infection
8. Blood constitution disorders
9. Contraindications to the administration of raltegravir or maraviroc
10. Circulating CD4 nadir <100/mm3 in the natural history of HIV-1 infection.

Contacts and Locations

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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lafeuillade A, Assi A, Poggi C, Bresson-Cuquemelle C, Jullian E, Tamalet C. Failure of combined antiretroviral therapy intensification with maraviroc and raltegravir in chronically HIV-1 infected patients to reduce the viral reservoir: the IntensHIV randomized trial. AIDS Res Ther. 2014 Oct 7;11(1):33. doi: 10.1186/1742-6405-11-33. eCollection 2014.

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
First Posted:	July 9, 2009
Last Update Posted:	May 12, 2017
Last Verified:	May 2017

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