Human Immunodeficiency Virus (HIV)Phase 1NCT03407105
A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
A Phase 1 study testing MDX-010 in people with Human Immunodeficiency Virus (HIV), run by Bristol-Myers Squibb at 5 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- MDX-010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Apr 2003to 21 Feb 2006
- Phase
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Detectable HIV viremia (HIV-1 RNA level between 1,000 and 100,000 copies/mL)
- CD4 count greater than or equal to 100 cells/mm3
- Current antiretroviral therapy regimen following at least 2 previous changes for documented virologic failure
- Documented resistance tests demonstrating the presence of at least 1 mutation to each major therapeutic class of antiretroviral therapy
- No significant organ compromise
Who cannot join
- Initiation of any new medications that might reasonably affect the immune response or viral load within 4 weeks prior to screening
- Tetanus booster immunization within 2 months of screening, or a history of anaphylaxis or severe local reaction to the tetanus vaccine
- History of autoimmune disease at risk for recurrence
- Current malignancy, except Stage A or B cervical carcinoma or basal cell carcinoma
- Chronic viral hepatitis, due to Hepatitis B or Hepatitis C undergoing current treatment or Hepatitis B DNA greater than 25 pg/cc or Hepatitis C RNA greater than 20,000 IU/cc
- Currently undergoing treatment or prophylaxis for tuberculosis infection
- Chronic active infectious disease (other than HIV)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Shannon Schrader, MD
Houston, Texas, 77098
Tower ID Medical Associates
Los Angeles, California, 90048
Care Resource
Miami, Florida, 33137
Orlando Immunology Center
Orlando, Florida, 32803
Quest Clinical Research
San Francisco, California, 94115
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus
The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- MDX-010
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-010Biological
Also called Ipilimumab, BMS-734016
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Experimental | Specified dose on specified days Receives: Biological: MDX-010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment induced dose limiting toxicities (DLTs)
Measured: Up to 141 days
Grade of treatment induced DLTs
Measured: Up to 141 days
Number of treatment emergent AEs (adverse events)
Measured: Up to 141 days
Secondary outcomes (15)
Maximum plasma concentration observed post-dose (Cmax)
Measured: Up to 141 days
Time of maximum plasma concentration observed post-dose (Tmax)
Measured: Up to 141 days
HIV Ribonucleic Acid (RNA) level
Measured: Up to 141 days
CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens
Measured: Up to 141 days
CD4 T cell cytokine responses to Candida antigen
Measured: Up to 141 days
CD4 T cell cytokine responses to tetanus antigen
Measured: Up to 141 days
CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens
Measured: Up to 141 days
CD8 T cell cytokine responses to Candida antigen
Measured: Up to 141 days
CD8 T cell cytokine responses to tetanus antigen
Measured: Up to 141 days
Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens
Measured: Up to 141 days
LPA to Candida antigens
Measured: Up to 141 days
LPA to tetanus antigens
Measured: Up to 141 days
Anti-tetanus toxin antibody level
Measured: Up to 141 days
Number of CD4 T cells
Measured: Up to 141 days
Number of CD8 T cells
Measured: Up to 141 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start21 Apr 2003
- Primary completion21 Feb 2006
- Study completion21 Feb 2006
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 Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medarex
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407105
- Sponsor's protocol ID
- MDX010-10
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Colston E, Grasela D, Gardiner D, Bucy RP, Vakkalagadda B, Korman AJ, Lowy I. An open-label, multiple ascending dose study of the anti-CTLA-4 antibody ipilimumab in viremic HIV patients. PLoS One. 2018 Jun 7;13(6):e0198158. doi: 10.1371/journal.pone.0198158. eCollection 2018.
PubMed 29879143
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT03407105
- Acronym / sponsor ID
- MDX010-10
- Conditions
- Human Immunodeficiency Virus (HIV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Medarex
- Study start
- 21 Apr 2003 (actual)
- Primary completion
- 21 Feb 2006 (actual)
- Study completion
- 21 Feb 2006 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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 purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Experimental | Biological: MDX-010Specified dose on specified days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Detectable HIV viremia (HIV-1 RNA level between 1,000 and 100,000 copies/mL)
- CD4 count greater than or equal to 100 cells/mm3
- Current antiretroviral therapy regimen following at least 2 previous changes for documented virologic failure
- Documented resistance tests demonstrating the presence of at least 1 mutation to each major therapeutic class of antiretroviral therapy
- No significant organ compromise
Key exclusion criteria (7 listed)
- Initiation of any new medications that might reasonably affect the immune response or viral load within 4 weeks prior to screening
- Tetanus booster immunization within 2 months of screening, or a history of anaphylaxis or severe local reaction to the tetanus vaccine
- History of autoimmune disease at risk for recurrence
- Current malignancy, except Stage A or B cervical carcinoma or basal cell carcinoma
- Chronic viral hepatitis, due to Hepatitis B or Hepatitis C undergoing current treatment or Hepatitis B DNA greater than 25 pg/cc or Hepatitis C RNA greater than 20,000 IU/cc
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 |
|---|---|---|
| MDX-010Also: Ipilimumab, BMS-734016Specified dose on specified days | Biological | Arm 2 |
Primary outcome
Number of treatment induced dose limiting toxicities (DLTs)
Time frame: Up to 141 days
Grade of treatment induced DLTs
Time frame: Up to 141 days
Number of treatment emergent AEs (adverse events)
Time frame: Up to 141 days
15 secondary outcomes
Maximum plasma concentration observed post-dose (Cmax)
Time frame: Up to 141 days
Time of maximum plasma concentration observed post-dose (Tmax)
Time frame: Up to 141 days
HIV Ribonucleic Acid (RNA) level
Time frame: Up to 141 days
CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens
Time frame: Up to 141 days
CD4 T cell cytokine responses to Candida antigen
Time frame: Up to 141 days
CD4 T cell cytokine responses to tetanus antigen
Time frame: Up to 141 days
CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens
Time frame: Up to 141 days
CD8 T cell cytokine responses to Candida antigen
Time frame: Up to 141 days
CD8 T cell cytokine responses to tetanus antigen
Time frame: Up to 141 days
Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens
Time frame: Up to 141 days
LPA to Candida antigens
Time frame: Up to 141 days
LPA to tetanus antigens
Time frame: Up to 141 days
Anti-tetanus toxin antibody level
Time frame: Up to 141 days
Number of CD4 T cells
Time frame: Up to 141 days
Number of CD8 T cells
Time frame: Up to 141 days
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 23 Jan 2018.
- Derived from this study: PubMed 29879143Colston E, Grasela D, Gardiner D, Bucy RP, Vakkalagadda B, Korman AJ, Lowy I. An open-label, multiple ascending dose study of the anti-CTLA-4 antibody ipilimumab in viremic HIV patients. PLoS One. 2018 Jun 7;13(6):e0198158. doi: 10.1371/journal.pone.0198158. eCollection 2018.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDX-010 in people with Human Immunodeficiency Virus (HIV), run by Bristol-Myers Squibb at 5 sites in United States.
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 5 inclusion and 7 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of treatment induced dose limiting toxicities (DLTs) (time frame: Up to 141 days). 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 NCT03407105, 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 23 Jan 2018.