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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002276
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1990
History of Changes
  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:

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:

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 May 19, 2013