The Effects of AZT and Ibuprofen on HIV-Infected Patients... | NCT00002276

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

NCT00002276

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

HIV Infections
Hemophilia A

Interventions

Ibuprofen
Zidovudine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 1990

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hemophilia Ctr of Western PA / Univ of Pittsburgh		Pittsburgh	Pennsylvania	15219	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1609771	Background	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.

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen	Drug
Zidovudine	Drug

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

ID	Term
D015658	HIV Infections
D006467	Hemophilia A