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Completed

NCT Number: NCT00935480

IntensVIH: 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isentress®

Drug

P.O, 1 tablet containing 400 mg every 12 hours

Celsentri®

Drug

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 outcomes

  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 outcomes

  1. CD4 counts

    Time frame: one year

  2. CD8 activation levels

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Collaborators

  • Abbott
  • Merck Sharp & Dohme LLC

Registry information

Official study title

IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS

Acronym: IntensVIH

Important dates

Study start
2010
Primary completion
2010
Study completion
2014
First posted
Jul 9, 2009
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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