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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	University of Pittsburgh
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002276

Purpose

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.

Condition	Intervention
HIV Infections Hemophilia A	Drug: Ibuprofen Drug: Zidovudine

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Study of Bleeding Tendency, Platelet Function, and Pharmacokinetics of Azidothymidine (AZT) and Motrin (Ibuprofen) in HIV-Infected Hemophiliacs

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency hemophilia Help Me Understand Genetics

MedlinePlus related topics: Bleeding Disorders Drug Reactions HIV/AIDS Hemophilia

Drug Information available for: Ibuprofen Zidovudine

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002276

Locations

United States, Pennsylvania
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219

Sponsors and Collaborators

University of Pittsburgh

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00002276 History of Changes
Other Study ID Numbers:	044A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Blood Platelets
Ibuprofen
Drug Interactions
Zidovudine
Hemophilia A

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Hemophilia A
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases

Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Ibuprofen
Zidovudine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012