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The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia

Primary Purpose

HIV Infections, Hemophilia A

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Zidovudine
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Blood Platelets, Ibuprofen, Drug Interactions, Zidovudine, Hemophilia A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have: Hemophilia. HIV-seropositivity confirmed by Western Blot. Prior Medication: Required: - AZT for study patients. Allowed: - Ibuprofen. Exclusion Criteria 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).

Sites / Locations

  • Hemophilia Ctr of Western PA / Univ of Pittsburgh

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00002276
Brief Title
The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia
Official Title
Study of Bleeding Tendency, Platelet Function, and Pharmacokinetics of Azidothymidine (AZT) and Motrin (Ibuprofen) in HIV-Infected Hemophiliacs
Study Type
Interventional

2. Study Status

Record Verification Date
June 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hemophilia A
Keywords
Blood Platelets, Ibuprofen, Drug Interactions, Zidovudine, Hemophilia A

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: Hemophilia. HIV-seropositivity confirmed by Western Blot. Prior Medication: Required: - AZT for study patients. Allowed: - Ibuprofen. Exclusion Criteria 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).
Facility Information:
Facility Name
Hemophilia Ctr of Western PA / Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1609771
Citation
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.
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The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia

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