HIV-1 InfectionEarly Phase 1CHEMOMARNCT02486510
Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication
A Early Phase 1 study testing Maraviroc in people with HIV-1 Infection, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites in Spain.
Trial summary
Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesSpain
- Study dates
- Jul 2012to Dec 2015
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who give written consent to participate in the study
- Age between 18 and 65 years old, included.
- Chronic HIV-1 Demonstration of R5 viral tropism (use of CCR5 coreceptors) by genotyping in plasma samples stored
- Patients that are to be treated with intensive chemotherapy for non Hodgkin lymphoma With or without stable antiretroviral therapy
- Patients that are able to understand the purpose of the study and be available for scheduled appointments.
- Both in the case of female and male patients, the patient agrees to use a double barrier method of contraception from the moment of signing the informed consent until 3 months after the end of their participation in the study.
Who cannot join
- To have planned antiretroviral treatment interruption during the participation in the study
- Hypersensitivity to products used in this study
- To be involved in another clinical trial or received an investigational drug within 3 months prior to the study initiation
- To have contraindications or limitations to perform leukapheresis
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Ramon Y Cajal
Madrid, Madrid, 28034
Hospital Universitario La Paz
Madrid, Madrid, 28046
About this study
Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial.
- Conditions
- HIV-1 Infection
- Being tested
- Maraviroc
- Keywords
- HIV-1, CCR5 coreceptors, Maraviroc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Celsentri
Patients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery.
Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose will be reduced to 150 mg/12hours For patients receiving Efavirenz dose the dose will be 600 mg/12hours
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control) | No intervention | Patients receiving intensive chemotherapy with/without stable antiretroviral therapy. Patients not receiving antiretroviral therapy will start it. Patients randomized to this group will not receive clinical trial treatment (neither Maraviroc or Placebo) |
| Group 2 (Treatment) | Experimental | Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc.
Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc. Receives: Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM
Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Measured: Same as chemotherapy treatment (expected average of 6 months)
Secondary outcomes (4)
Proviral DNA (copies/million cells)
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Measured: Same as chemotherapy treatment (expected average of 6 months)
Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Measured: Same as chemotherapy treatment (expected average of 6 months)
Levels of HIV-1 antibodies
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Measured: Same as chemotherapy treatment (expected average of 6 months)
Percentage of CD4+ and CD8+ cells with immune activation markers
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Measured: Same as chemotherapy treatment (expected average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Futility criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486510
- Sponsor's protocol ID
- CHEMOMAR
- Acronym
- CHEMOMAR
- Status last verified
- Dec 2015
- First submitted
- 24 Jun 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang C, Vlahov D, Galai N, Bareta J, Strathdee SA, Nelson KE, Sterling TR. Mortality in HIV-seropositive versus -seronegative persons in the era of highly active antiretroviral therapy: implications for when to initiate therapy. J Infect Dis. 2004 Sep 15;190(6):1046-54. doi: 10.1086/422848. Epub 2004 Aug 17.
PubMed 15319852Moreno S, Mocroft A, Monforte Ad. Medical and societal consequences of late presentation. Antivir Ther. 2010;15 Suppl 1:9-15. doi: 10.3851/IMP1523.
PubMed 20442456Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193.
PubMed 9371822Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295.
PubMed 9360927
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication
- ClinicalTrials.gov ID
- NCT02486510
- Acronym / sponsor ID
- CHEMOMAR / CHEMOMAR
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1, CCR5 coreceptors, Maraviroc
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility criteria
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jul 2015 (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.
Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control) | No intervention | –Patients receiving intensive chemotherapy with/without stable antiretroviral therapy. Patients not receiving antiretroviral therapy will start it. Patients randomized to this group will not receive clinical trial treatment (neither Maraviroc or Placebo) |
| Group 2 (Treatment) | Experimental | Drug: MaravirocPatients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc. Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who give written consent to participate in the study
- Age between 18 and 65 years old, included.
- Chronic HIV-1 Demonstration of R5 viral tropism (use of CCR5 coreceptors) by genotyping in plasma samples stored
- Patients that are to be treated with intensive chemotherapy for non Hodgkin lymphoma With or without stable antiretroviral therapy
- Patients that are able to understand the purpose of the study and be available for scheduled appointments.
Key exclusion criteria (4 listed)
- To have planned antiretroviral treatment interruption during the participation in the study
- Hypersensitivity to products used in this study
- To be involved in another clinical trial or received an investigational drug within 3 months prior to the study initiation
- To have contraindications or limitations to perform leukapheresis
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 |
|---|---|---|
| MaravirocAlso: CelsentriPatients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery. Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose will be reduced to 150 mg/12hours For patients receiving Efavirenz dose the dose will be 600 mg/12hours | Drug | Group 2 (Treatment) |
Primary outcome
number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
4 secondary outcomes
Proviral DNA (copies/million cells)
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Levels of HIV-1 antibodies
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Percentage of CD4+ and CD8+ cells with immune activation markers
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Results and safety
The study was stopped early (reason given: Futility criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Background: PubMed 15319852Wang C, Vlahov D, Galai N, Bareta J, Strathdee SA, Nelson KE, Sterling TR. Mortality in HIV-seropositive versus -seronegative persons in the era of highly active antiretroviral therapy: implications for when to initiate therapy. J Infect Dis. 2004 Sep 15;190(6):1046-54. doi: 10.1086/422848. Epub 2004 Aug 17.
- Background: PubMed 20442456Moreno S, Mocroft A, Monforte Ad. Medical and societal consequences of late presentation. Antivir Ther. 2010;15 Suppl 1:9-15. doi: 10.3851/IMP1523.
- Background: PubMed 9371822Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193.
- Background: PubMed 9360927Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295.
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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 Early Phase 1 study testing Maraviroc in people with HIV-1 Infection, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Dec 2015. 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Futility criteria). Results are not available in the source record.
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?
number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM (time frame: Same as chemotherapy treatment (expected average of 6 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 NCT02486510, which also lists 4 linked publications.
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 18 Dec 2015.