Pneumonia, Pneumocystis CariniiPhase 2NCT00001996
A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole
A Phase 2 study testing Atovaquone and Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by Glaxo Wellcome at 20 sites in United States.
Trial summary
To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- What is being tested?
- Atovaquone and Pentamidine isethionate
- How many people
- Not given
- Where
- 20 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have the following:
- History of, or are currently experiencing, intolerance to TMP / SMX, or to another sulfonamide, which required discontinuation of therapy.
- Pneumocystis carinii pneumonia (PCP).
- Willing and able to give informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded.
- Malabsorption disorder or vomiting that would, in the judgement of the investigator, potentially limit the retention and absorption of an oral therapy.
- Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma, or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult.
- Present occurrences of abnormal prolongation of QT interval on standard, 12 lead EKG.
- Concurrent Medication:
Show all 30Show fewer
- Excluded:
- Drugs with potential anti-pneumocystis effect (eg:
- sulfonamides, dapsone, trimethoprim, other dihydrofolate reductase (DHFR) inhibitors, primaquine, clindamycin, sulfonylureas).
- Ganciclovir.
- Zidovudine.
- Investigational agents including anti-retroviral agents (ddI, ddC, etc.). Patients receiving these drugs prior to entry must discontinue their use during the therapy phase (21 days) of the trial.
- Corticosteroids (except replacement therapy) during the 21 day treatment period (Strata A and C Patients).
- Class 1A antiarrhythmics (ie:
- quinidine, procainamide, disopyramide).
- Patients with the following are excluded:
- Judged by the investigator to be in impending respiratory failure.
- Known intolerance to parenteral pentamidine isethionate, or therapeutic failure with same for treatment of current episode of PCP.
- Significant psychosis or emotional disorder that, in the investigator's opinion, would preclude the patient from adhering to the protocol.
- Inability or unwillingness to take medication orally or with food.
- Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- History, or present occurrences, of abnormal prolongation of QT interval on standard, 12 lead EKG.
- Termination from FDA 053A due to toxicity.
- For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion.
- Prior Medication:
- Excluded:
- Treatment within 4 weeks of entry for a prior episode of PCP.
- For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion.
- Required:
- Adjuvant prednisone for patient enrolled in Strata B or D.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345
East Bay AIDS Ctr
Berkeley, California, 94704
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Boston City Hosp
Boston, Massachusetts, 02118
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Kaiser Foundation Hosp
Harbor City, California, 90710
Gathe, Joseph, M.D.
Houston, Texas, 77004
Baylor College of Medicine
Houston, Texas, 77030
Cedars Sinai Med Ctr
Los Angeles, California, 90048
UCLA CARE Ctr
Los Angeles, California, 90095
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
Beth Israel Med Ctr
New York, New York, 10003
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
UCI Med Ctr
Orange, California, 92668
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
AIDS Community Research Consortium
Redwood City, California, 94063
Davies Med Ctr
San Francisco, California, 94114
Dr Patrick Joseph
San Ramone, California, 94583
About this study
To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the same population.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Being tested
- Atovaquone, Pentamidine isethionate
- Keywords
- Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Pentamidine, Acquired Immunodeficiency Syndrome, atovaquone
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtovaquoneDrug
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 (1)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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001996
- Sponsor's protocol ID
- 053B
- Other IDs
- 05
- Status last verified
- May 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Dohn M, Weinberg W, Rosenstock J, Follansbee S, Torres R, Caldwell P. Atovaquone vs. pentamidine for pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):372 (abstract no PO-B10-1421)
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 Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole
- ClinicalTrials.gov ID
- NCT00001996
- Acronym / sponsor ID
- 053B
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Pentamidine, Acquired Immunodeficiency Syndrome, atovaquone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (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 compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the same population.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- History of, or are currently experiencing, intolerance to TMP / SMX, or to another sulfonamide, which required discontinuation of therapy.
- Pneumocystis carinii pneumonia (PCP).
- Willing and able to give informed consent.
Key exclusion criteria (30 listed)
- Patients with the following conditions or symptoms are excluded.
- Malabsorption disorder or vomiting that would, in the judgement of the investigator, potentially limit the retention and absorption of an oral therapy.
- Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma, or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult.
- Present occurrences of abnormal prolongation of QT interval on standard, 12 lead EKG.
- Drugs with potential anti-pneumocystis effect (eg:
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 |
|---|---|---|
| Atovaquone | Drug | – |
| 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.
- BackgroundDohn M, Weinberg W, Rosenstock J, Follansbee S, Torres R, Caldwell P. Atovaquone vs. pentamidine for pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):372 (abstract no PO-B10-1421)
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atovaquone and Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by Glaxo Wellcome at 20 sites 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 4 inclusion and 30 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 20 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00001996, 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.