HIV-1Phase 2NCT00807443
Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1
A Phase 2 study testing Raltegravir in people with HIV-1 and HIV Infections, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1, HIV Infections
- What is being tested?
- Raltegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 2
- 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
- After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
- Aged over 18 years.
- Chronic HIV infection
- Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
- Undetectable viral load determined by ultrasensitive techniques (<50 copies HIV RNA/mL) for at least 2 years.
- CD4+ T lymphocyte count above 350 cells/mm3.
- Understand the objective of the study and be available to make frequent visits to the hospital.
Who cannot join
- Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
- Proven resistance against the antiretroviral drugs under study.
- Planned interruption of antiretroviral therapy.
- Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
- Taking a fusion inhibitor (enfuvirtide).
- Pregnancy or intention to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Of The Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy
The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.
Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with an integrase inhibitor is exceptional, since the results could provide important information on the nature of this reservoir.
Read more
If maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).
The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.
- Conditions
- HIV-1, HIV Infections
- Being tested
- Raltegravir
- Keywords
- HIV-1, integrase inhibitor (raltegravir), the cell reservoir of HIV-1, 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.
RaltegravirDrug
Raltegravir (INN), 400 mg tablets, developed and supplied by Merck Sharp \& Dohme. A dose of 400 mg will be administered every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | Not described Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate, by means of a clinical trial, the effect of therapy with an integrase inhibitor (Raltegravir) on the cell reservoir of HIV-1 on patients taking HAART
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
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-1Studies 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Santiago Moreno Guillen, MD,PhD, Principal investigator, HOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807443
- Sponsor's protocol ID
- ERRADVIH-02
- Status last verified
- Jan 2013
- First submitted
- 11 Dec 2008
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Serrano-Villar S, Gutierrez C, Vallejo A, Hernandez-Novoa B, Diaz L, Abad Fernandez M, Madrid N, Dronda F, Zamora J, Munoz-Fernandez MA, Moreno S. The CD4/CD8 ratio in HIV-infected subjects is independently associated with T-cell activation despite long-term viral suppression. J Infect. 2013 Jan;66(1):57-66. doi: 10.1016/j.jinf.2012.09.013. Epub 2012 Oct 6.
PubMed 23046968
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Of The Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00807443
- Acronym / sponsor ID
- ERRADVIH-02
- Conditions
- HIV-1, HIV Infections
- Keywords
- HIV-1, integrase inhibitor (raltegravir), the cell reservoir of HIV-1, treatment experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Dec 2008 (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.
The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.
Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with an integrase inhibitor is exceptional, since the results could provide important information on the nature of this reservoir.
If maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).
The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Drug: Raltegravir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
- Aged over 18 years.
- Chronic HIV infection
- Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
- Undetectable viral load determined by ultrasensitive techniques (<50 copies HIV RNA/mL) for at least 2 years.
Key exclusion criteria (6 listed)
- Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
- Proven resistance against the antiretroviral drugs under study.
- Planned interruption of antiretroviral therapy.
- Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
- Taking a fusion inhibitor (enfuvirtide).
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 |
|---|---|---|
| RaltegravirRaltegravir (INN), 400 mg tablets, developed and supplied by Merck Sharp \& Dohme. A dose of 400 mg will be administered every 12 hours | Drug | Raltegravir |
Primary outcome
To evaluate, by means of a clinical trial, the effect of therapy with an integrase inhibitor (Raltegravir) on the cell reservoir of HIV-1 on patients taking HAART
Time frame: 12 months
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 1 Feb 2013.
- Derived from this study: PubMed 23046968Serrano-Villar S, Gutierrez C, Vallejo A, Hernandez-Novoa B, Diaz L, Abad Fernandez M, Madrid N, Dronda F, Zamora J, Munoz-Fernandez MA, Moreno S. The CD4/CD8 ratio in HIV-infected subjects is independently associated with T-cell activation despite long-term viral suppression. J Infect. 2013 Jan;66(1):57-66. doi: 10.1016/j.jinf.2012.09.013. Epub 2012 Oct 6.
Related trials for HIV-1
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
Santiago Moreno Guillen, MD,PhD principal investigator
HOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltegravir in people with HIV-1 and HIV Infections, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 7 inclusion and 6 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 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate, by means of a clinical trial, the effect of therapy with an integrase inhibitor (Raltegravir) on the cell reservoir of HIV-1 on patients taking HAART (time frame: 12 months). 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 NCT00807443, 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 1 Feb 2013.