HIV InfectionsNCT00002276
The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia
A study testing Ibuprofen and Zidovudine in people with HIV Infections and Hemophilia A, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections, Hemophilia A
- What is being tested?
- Ibuprofen and Zidovudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Hemophilia.
- HIV-seropositivity confirmed by Western Blot.
- Prior Medication:
- Required:
- AZT for study patients.
- Allowed:
- Ibuprofen.
Who cannot join
- 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).
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Study of Bleeding Tendency, Platelet Function, and Pharmacokinetics of Azidothymidine (AZT) and Motrin (Ibuprofen) in HIV-Infected Hemophiliacs
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.
- Conditions
- HIV Infections, Hemophilia A
- Being tested
- Ibuprofen, Zidovudine
- Keywords
- Blood Platelets, Ibuprofen, Drug Interactions, Zidovudine, Hemophilia A
- Medical subject headings
- HIV Infections, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002276
- Sponsor's protocol ID
- 044A
- Status last verified
- Jun 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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. doi: 10.1002/ajh.2830400305.
PubMed 1609771
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bleeding Tendency, Platelet Function, and Pharmacokinetics of Azidothymidine (AZT) and Motrin (Ibuprofen) in HIV-Infected Hemophiliacs
- ClinicalTrials.gov ID
- NCT00002276
- Acronym / sponsor ID
- 044A
- Conditions
- HIV Infections, Hemophilia A
- Keywords
- Blood Platelets, Ibuprofen, Drug Interactions, Zidovudine, Hemophilia A
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Hemophilia.
- HIV-seropositivity confirmed by Western Blot.
- AZT for study patients.
- Ibuprofen.
Key exclusion criteria (12 listed)
- Hospitalization for opportunistic infection, bacterial infection or malignancy.
- AZT (for control group).
- Antibiotics or other medication for opportunistic infection, bacterial infection, or malignancy.
- Hospitalization for opportunistic infection, bacterial infection, or malignancy.
- Ibuprofen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 1609771Ragni 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and Zidovudine in people with HIV Infections and Hemophilia A, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.