A Phase 1 interventional study of MDX-010 in Human Immunodeficiency Virus (HIV), sponsored by Bristol-Myers Squibb. Completed at 5 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 24 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Bristol-Myers Squibb is the lead sponsor of 1,560 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Specified dose on specified days
Biological: MDX-010
Specified dose on specified days
Also known as: Ipilimumab, BMS-734016
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
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
Ran from Apr 2003 to primary completion in Feb 2006, 34 months.
Of 76 industry-sponsored phase 1 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's 34 months is above that.
Counting every sponsor, half of 139 studies reached it within 14 months; a quarter within 4 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ipilimumab
Acquired Immunodeficiency Syndrome →