Pneumonia, Pneumocystis CariniiPhase 1NCT00000773
Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children
A Phase 1 study testing Atovaquone in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 2 countries.
Trial summary
To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and… Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- What is being tested?
- Atovaquone
- How many people
- 24 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Start not givento Sep 1996
- Phase
- Phase 1
- 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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- Dideoxycytidine (zalcitabine; ddC).
- Didanosine (ddI).
- Nonaminoglycoside, nonmacrolide, and nonsulfonamide antibiotics.
Show all 17Show fewer
- Factor VIII.
- IVIG.
- Patients must have:
- AIDS, documented HIV infection, perinatal exposure to HIV, or risk of developing PCP.
- Normal EKG and chest radiograph.
- No blood or protein on urinalysis.
- Consent of parent or guardian.
- Prior Medication:
- Allowed:
- Prophylactic TMP/SMX if given no less than 3 days prior to study entry.
- Prophylactic aerosolized pentamidine (or a single intravenous dose of 4.0 mg/kg pentamidine) if given no less than 7 days prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Anticipated organ system or laboratory abnormalities (other than immune system abnormalities) from the primary disease and its treatment during the study.
- Acute or chronic infections requiring treatment during the study. NOTE:
- Thrush and herpes labialis are allowed if these conditions do not require treatment.
- Diarrhea or vomiting.
Show all 26Show fewer
- Concurrent Medication:
- Excluded:
- Trimethoprim/sulfamethoxazole.
- Sulfadoxine and pyrimethamine (Fansidar).
- Primaquine.
- Aspirin.
- Amphotericin B.
- Aminoglycoside antibiotics.
- Sulfonamides.
- Dapsone.
- Benzodiazepines.
- Rifampin.
- Erythromycin, clarithromycin, and azithromycin.
- Digitalis.
- Para-aminosalicylic acid (PAS).
- Isoniazid.
- Anticoagulants.
- Any other investigational therapies.
- Patients with the following prior condition are excluded:
- History of G6PD deficiency.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Chicago Children's CRS
Chicago, Illinois, 60614
DUMC Ped. CRS
Durham, North Carolina
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana
UCSF Pediatric AIDS CRS
San Francisco, California, 94143
Puerto Rico1 site
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00936
About this study
To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP).
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
Read the detailed description
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
Three cohorts of four patients each (ages 2-12 years, 3 months to less than 2 years, and 1 month to less than 3 months) receive atovaquone daily for 12 days. The oldest age group is treated first. In the absence of unacceptable toxicity, the dose of atovaquone is escalated in subsequent 4-patient cohorts representing each of the age stratifications and (per 9/30/94 amendment) in a separate 4-patient cohort aged 3 months to less than 2 years. If two of four patients in a given cohort experience unacceptable toxicity at the initial dose, two additional patients in the same age range are entered. Blood samples are drawn for pharmacokinetic evaluation. Patients are followed to day 24. Per 9/30/94 amendment, patients aged 3 months to less than 2 years of age who received one of the lower doses may re-enroll in the higher dose cohort after a 1-month washout.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Being tested
- Atovaquone
- Keywords
- Pneumonia, Pneumocystis carinii, Antifungal Agents, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Biological Availability, atovaquone
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtovaquoneDrug
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)
- Study completionSep 1996
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 1
- Primary purpose
- Prevention
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hughes W, Study chairDorenbaum A, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000773
- Sponsor's protocol ID
- ACTG 227
- Other IDs
- 11204
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Publications
Dorenbaum A, Sadler BM, Xu J, Van Dyke RB, Wei LJ, Moye J, McNamara J, Yogev R, Diaz C, Hughes W. Phase I safety and pharmacokinetics (PK) study of micronized atovaquone (m-ATQ) in HIV exposed or infected infants and children. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:117 (abstract no 288)
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children
- ClinicalTrials.gov ID
- NCT00000773
- Acronym / sponsor ID
- ACTG 227
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Pneumonia, Pneumocystis carinii, Antifungal Agents, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Biological Availability, atovaquone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Sep 1996 (actual)
- 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 the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP).
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
Detailed description
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
Three cohorts of four patients each (ages 2-12 years, 3 months to less than 2 years, and 1 month to less than 3 months) receive atovaquone daily for 12 days. The oldest age group is treated first. In the absence of unacceptable toxicity, the dose of atovaquone is escalated in subsequent 4-patient cohorts representing each of the age stratifications and (per 9/30/94 amendment) in a separate 4-patient cohort aged 3 months to less than 2 years. If two of four patients in a given cohort experience unacceptable toxicity at the initial dose, two additional patients in the same age range are entered. Blood samples are drawn for pharmacokinetic evaluation. Patients are followed to day 24. Per 9/30/94 amendment, patients aged 3 months to less than 2 years of age who received one of the lower doses may re-enroll in the higher dose cohort after a 1-month washout.
Study design
- Primary purpose
- Prevention
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Zidovudine (AZT).
- Dideoxycytidine (zalcitabine; ddC).
- Didanosine (ddI).
- Nonaminoglycoside, nonmacrolide, and nonsulfonamide antibiotics.
- Factor VIII.
Key exclusion criteria (26 listed)
- Anticipated organ system or laboratory abnormalities (other than immune system abnormalities) from the primary disease and its treatment during the study.
- Acute or chronic infections requiring treatment during the study. NOTE:
- Thrush and herpes labialis are allowed if these conditions do not require treatment.
- Diarrhea or vomiting.
- Trimethoprim/sulfamethoxazole.
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 | – |
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 28 Oct 2021.
- BackgroundDorenbaum A, Sadler BM, Xu J, Van Dyke RB, Wei LJ, Moye J, McNamara J, Yogev R, Diaz C, Hughes W. Phase I safety and pharmacokinetics (PK) study of micronized atovaquone (m-ATQ) in HIV exposed or infected infants and children. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:117 (abstract no 288)
Related trials for Pneumonia, Pneumocystis Carinii
RecruitingPhase 3
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Pneumocystis, Pneumocystis Pneumonia
Not yet recruitingPhase 4
Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)
Pneumocystis, Pneumocystis Infection
Not yet recruitingPhase 4
How Long Should we Give Steroids for Patients With Severe PCP
Pneumocystis Pneumonia, Pneumocystis
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.
Hughes W study chair
Dorenbaum A study chair
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atovaquone in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 2 countries.
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 17 inclusion and 26 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Puerto Rico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 NCT00000773, 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 28 Oct 2021.