Predictors of Drug Hypersensitivity in HIV Infected Subjects
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ClinicalTrials.gov Identifier: NCT00168220 |
Recruitment Status
:
Withdrawn
(Insufficient recruitment)
First Posted
: September 15, 2005
Last Update Posted
: January 20, 2012
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Condition or disease |
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HIV Infections Hypersensitivity |
- To determine in a case control study clinical parameters associated with drug HSR to abacavir, nevirapine and efavirenz in HIV infected subjects.
- To measure functional and numerical differences in DC populations and responses to TLR ligands in patients with HSR and tolerant subjects sharing genetic markers for susceptibility to HSR.
- Identify the role of different DC populations in the development of abacavir reaction by mixing and depletion studies in sensitized subjects and in in vitro assays for abacavir hypersensitivity.
- To measure T cell parameters including T cell viability in culture, and expression of fas and fasL on blood mononuclear cells in HIV infected controls and HSR patients.
- To measure blood T cell populations including drug reactive T cells and T regulatory cells in tolerant and reactive subjects with genetic susceptibility to Abacavir and Nevirapine HSR.
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case Control |
Time Perspective: | Retrospective |
Official Title: | Predictors of Drug Hypersensitivity in HIV Infected Subjects |
Study Start Date : | August 2005 |
Group/Cohort |
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Drug hypersensitive group
HIV positive patients with a history of a Hypersensitivity Reaction to the antiretroviral medications Nevirapine, Abacavir or Efavirenz
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Drug tolerant group
HIV positive patients selected based on drug exposure greater than 2 weeks and tolerance to to Abacavir or Nevirapine.
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV infected patients on treatment with the drugs Efavirenz, Nevirapine, or Abacavir.
- Age over 18 Cases are those who have had a hypersensitivity reaction, and controls are those who have had no reaction

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168220
Australia, Victoria | |
Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Paul Cameron, Dr | The Alfred |
Responsible Party: | Jennifer Hoy, Professor Jennifer Hoy, The Alfred |
ClinicalTrials.gov Identifier: | NCT00168220 History of Changes |
Other Study ID Numbers: |
113/05 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | January 20, 2012 |
Last Verified: | January 2012 |
Keywords provided by Jennifer Hoy, The Alfred:
Treatment Experienced HIV |
Additional relevant MeSH terms:
HIV Infections Hypersensitivity Drug Hypersensitivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders |