HIV InfectionsPhase 3IntensVIHNCT00935480
IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients
A Phase 3 study testing Isentress® and Celsentri® in people with HIV Infections, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Isentress® and Celsentri®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to 8 Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
Toulon, 83056
Centre Hospitalier Intercommunal de Toulon La Seyne sur mer
Toulon, 83500
About this study
Official title: 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.
- Conditions
- HIV Infections
- Being tested
- Isentress®, Celsentri®
- Keywords
- HIV, INTEGRASE INHIBITOR, Inhibitor on the lymphoid reservoir, Residual HIV replication, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| HAART+Raltegravir 12 months (+/-) Maraviroc | Experimental | Not described Receives: Drug: Isentress®; Drug: Celsentri® |
| HAART | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual plasma replication between 0 and 50 copies/ml
Measured: one year
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL
Measured: one year
proviral HIV DNA levels in PBMC and RL
Measured: one year
Secondary outcomes (2)
CD4 counts
Measured: one year
CD8 activation levels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startOct 2010
- Primary completion12 Nov 2010
- Study completion8 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935480
- Sponsor's protocol ID
- CH-2009.01
- Acronym
- IntensVIH
- Status last verified
- May 2017
- First submitted
- 8 Jul 2009
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25320633
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS
- ClinicalTrials.gov ID
- NCT00935480
- Acronym / sponsor ID
- IntensVIH / CH-2009.01
- Conditions
- HIV Infections
- Keywords
- HIV, INTEGRASE INHIBITOR, Inhibitor on the lymphoid reservoir, Residual HIV replication, treatment experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Abbott
- Study start
- Oct 2010 (actual)
- Primary completion
- 12 Nov 2010 (actual)
- Study completion
- 8 Aug 2014 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAART+Raltegravir 12 months (+/-) Maraviroc | Experimental | Drug: Isentress®, Drug: Celsentri® |
| HAART | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isentress®P.O, 1 tablet containing 400 mg every 12 hours | Drug | HAART+Raltegravir 12 months (+/-) Maraviroc |
| 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) | Drug | HAART+Raltegravir 12 months (+/-) Maraviroc |
Primary outcome
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
2 secondary outcomes
CD4 counts
Time frame: one year
CD8 activation levels
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Derived from this study: PubMed 25320633Lafeuillade 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isentress® and Celsentri® in people with HIV Infections, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual plasma replication between 0 and 50 copies/ml (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.