Pneumonia, Pneumocystis CariniiNCT00002054
A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients
A study testing Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by Fisons at 1 site in United States.
Trial summary
To evaluate the safety, tolerability, and description of time to Pneumocystis carinii pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had one episode of AIDS-associated PCP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- What is being tested?
- Pentamidine isethionate
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have completed 16 treatments under Fisons study no. 87-71 entitled, "A Double-Blind Group Comparative Study To Evaluate the Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP." Detailed safety parameters must have been documented for 6 months.
- Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry:
- Toxoplasmosis.
- Cryptococcosis.
- Pulmonary Kaposi's sarcoma.
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- Asthma poorly controlled by medication.
- Receiving active therapy for tuberculosis.
- Patients with the following are excluded:
- Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry:
- Toxoplasmosis.
- Cryptococcosis.
- Pulmonary Kaposi's sarcoma.
- Unwilling to sign informed consent.
- Cannot cooperate with study procedures.
- Asthma poorly controlled by medication.
- Receiving active therapy for tuberculosis.
- Active substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety, tolerability, and description of time to Pneumocystis carinii pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had one episode of AIDS-associated PCP.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Being tested
- Pentamidine isethionate
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentamidine isethionateDrug
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 (4)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Pneumocystis CariniiStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Fisons
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002054
- Sponsor's protocol ID
- 022C
- Other IDs
- 87-71 (Part C)
- Status last verified
- Oct 1989
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Hogan CH, Hodges JS, Mugglin A, Peterson PM, Abrams DI, Saravolatz L. The perils of visit-driven endpoints in antiretroviral trials. Int Conf AIDS. 1996 Jul 7-12;11(1):237 (abstract no TuB522)
Wulfsohn M, Fischl M, Tsiatis A. Predictors of survival among patients with AIDS receiving zidovudine. Int Conf AIDS. 1992 Jul 19-24;8(2):C314 (abstract no PoC 4419)
De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1993 Apr;6(4):359-65.
PubMed 8095980Lavelle J, Murphy R, Harding P, Pierce P. Aerosolized pentamidine prophylaxis following Pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):374 (abstract no 2083)
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
- A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients
- ClinicalTrials.gov ID
- NCT00002054
- Acronym / sponsor ID
- 022C
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- FisonsIndustry (pharma, biotech, devices)
- 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 evaluate the safety, tolerability, and description of time to Pneumocystis carinii pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had one episode of AIDS-associated PCP.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have completed 16 treatments under Fisons study no. 87-71 entitled, "A Double-Blind Group Comparative Study To Evaluate the Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP." Detailed safety parameters must have been documented for 6 months.
- Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71.
Key exclusion criteria (18 listed)
- Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry:
- Toxoplasmosis.
- Cryptococcosis.
- Pulmonary Kaposi's sarcoma.
- Asthma poorly controlled by medication.
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 |
|---|---|---|
| Pentamidine isethionate | 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.
- BackgroundHogan CH, Hodges JS, Mugglin A, Peterson PM, Abrams DI, Saravolatz L. The perils of visit-driven endpoints in antiretroviral trials. Int Conf AIDS. 1996 Jul 7-12;11(1):237 (abstract no TuB522)
- BackgroundWulfsohn M, Fischl M, Tsiatis A. Predictors of survival among patients with AIDS receiving zidovudine. Int Conf AIDS. 1992 Jul 19-24;8(2):C314 (abstract no PoC 4419)
- Background: PubMed 8095980De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1993 Apr;6(4):359-65.
- BackgroundLavelle J, Murphy R, Harding P, Pierce P. Aerosolized pentamidine prophylaxis following Pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):374 (abstract no 2083)
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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 Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by Fisons 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 2 inclusion and 18 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 NCT00002054, which also lists 4 linked publications.
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.