Status:
COMPLETED
IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients
Lead Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Abbott
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00935480
Start Date
October 1 2010
End Date
August 8 2014
Last Update
May 12 2017
Active Locations (2)
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1
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
Toulon, France, 83056
2
Centre Hospitalier Intercommunal de Toulon La Seyne sur mer
Toulon, France, 83500