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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Isentress®
Celsentri®
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, INTEGRASE INHIBITOR, Inhibitor on the lymphoid reservoir, Residual HIV replication, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
  • Centre Hospitalier Intercommunal de Toulon La Seyne sur mer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HAART+Raltegravir 12 months (+/-) Maraviroc

HAART

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CD4 counts
CD8 activation levels

Full Information

First Posted
July 8, 2009
Last Updated
May 11, 2017
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Merck Sharp & Dohme LLC, Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00935480
Brief Title
IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients
Acronym
IntensVIH
Official Title
IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
November 12, 2010 (Actual)
Study Completion Date
August 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Merck Sharp & Dohme LLC, Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, INTEGRASE INHIBITOR, Inhibitor on the lymphoid reservoir, Residual HIV replication, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAART+Raltegravir 12 months (+/-) Maraviroc
Arm Type
Experimental
Arm Title
HAART
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Isentress®
Intervention Description
P.O, 1 tablet containing 400 mg every 12 hours
Intervention Type
Drug
Intervention Name(s)
Celsentri®
Intervention Description
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)
Primary Outcome Measure Information:
Title
residual plasma replication between 0 and 50 copies/ml
Time Frame
one year
Title
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL
Time Frame
one year
Title
proviral HIV DNA levels in PBMC and RL
Time Frame
one year
Secondary Outcome Measure Information:
Title
CD4 counts
Time Frame
one year
Title
CD8 activation levels
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
Centre Hospitalier Intercommunal de Toulon La Seyne sur mer
City
Toulon
ZIP/Postal Code
83500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25320633
Citation
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.
Results Reference
derived

Learn more about this trial

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

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