IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients (IntensVIH)
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ClinicalTrials.gov Identifier: NCT00935480 |
Recruitment Status
:
Completed
First Posted
: July 9, 2009
Last Update Posted
: May 12, 2017
|
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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 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 |

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 |
- residual plasma replication between 0 and 50 copies/ml [ Time Frame: one year ]
- intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL [ Time Frame: one year ]
- proviral HIV DNA levels in PBMC and RL [ Time Frame: one year ]
- CD4 counts [ Time Frame: one year ]
- CD8 activation levels [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935480
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |