NCT00002276

Brief Summary

To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsHemophilia A

Keywords

Blood PlateletsIbuprofenDrug InteractionsZidovudineHemophilia A

Interventions

IbuprofenDRUG
ZidovudineDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Hemophilia.
  • HIV-seropositivity confirmed by Western Blot.
  • Prior Medication:
  • Required:
  • \- AZT for study patients.
  • Allowed:
  • \- Ibuprofen.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Hospitalization for opportunistic infection, bacterial infection or malignancy.
  • Concurrent Medication:
  • Excluded:
  • AZT (for control group).
  • Antibiotics or other medication for opportunistic infection, bacterial infection, or malignancy.
  • Patients with the following prior conditions are excluded:
  • Hospitalization for opportunistic infection, bacterial infection, or malignancy.
  • Required:
  • Ibuprofen.
  • AZT 1-2 gm daily (for study patient) or not taking AZT (for control).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hemophilia Ctr of Western PA / Univ of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (1)

  • Ragni MV, Miller BJ, Whalen R, Ptachcinski R. Bleeding tendency, platelet function, and pharmacokinetics of ibuprofen and zidovudine in HIV(+) hemophilic men. Am J Hematol. 1992 Jul;40(3):176-82. doi: 10.1002/ajh.2830400305.

    PMID: 1609771BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHemophilia A

Interventions

IbuprofenZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1990-06

Locations

US(1)