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Trial record 1 of 1 for:    NCT00935480
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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

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

July 8, 2009
April 16, 2014
July 2010
July 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00935480 on ClinicalTrials.gov Archive Site
  • CD4 counts [ Time Frame: one year ] [ Designated as safety issue: No ]
  • CD8 activation levels [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients
IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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)
  • Experimental: HAART+Raltegravir 12 months (+/-) Maraviroc
    Interventions:
    • Drug: Isentress®
    • Drug: Celsentri®
  • No Intervention: HAART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
February 2013
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00935480
CH-2009.01
No
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  • Merck Sharp & Dohme Corp.
  • Abbott
Not Provided
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP