CryptosporidiosisPhase 2NCT00000771
A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3
A Phase 2 study testing Paromomycin sulfate in people with Cryptosporidiosis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in 2 countries.
Trial summary
To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cryptosporidiosis, HIV Infections
- What is being tested?
- Paromomycin sulfate
- How many people
- 68 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Start not givento Sep 1996
- 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
- Concurrent Medication:
- Allowed:
- Antiretroviral therapy.
- Macrolides for disseminated Mycobacterium avium.
- Atovaquone for toxoplasmosis.
- Other antimicrobials for concurrent infections.
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- Lomotil, Imodium, or deodorized opium tincture in a standardized regimen for diarrhea.
- Patients must have:
- Advanced HIV disease.
- Diarrhea presumptively caused by Cryptosporidia.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Hypersensitivity to aminoglycosides.
- Inability to swallow capsules.
- Active infection due to other enteric pathogens. Previous diagnosis of CMV or MAC infection permitted if patient is currently stabilized on a therapeutic regimen (clarithromycin up to 500 mg bid or azithromycin up to 600 mg daily).
- Other known causes for diarrhea (e.g., malabsorption syndrome, gastrointestinal Kaposi's sarcoma).
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- Concurrent Medication:
- Excluded during the first 9 weeks of study:
- Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum).
- Octreotide acetate (Sandostatin).
- Antidiarrheals other than those specifically allowed.
- Clarithromycin if initiated at 500 mg or higher or azithromycin if initiated at 600 mg or higher.
- Prior Medication:
- Excluded:
- Paromomycin at > 1 g/day for >= 14 days prior to study entry.
- Excluded within 14 days prior to study entry:
- Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum), with the exception of macrolides that are permitted for other indications.
- Octreotide acetate (Sandostatin).
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Northwestern University CRS
Chicago, Illinois, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Weiss Memorial Hosp.
Chicago, Illinois, 60640
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
Case CRS
Cleveland, Ohio, 44106
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202
USC CRS
Los Angeles, California
Univ. of Miami AIDS CRS
Miami, Florida, 33136
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Cornell University A2201
New York, New York, 10021
Washington U CRS
St Louis, Missouri
About this study
To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit.
In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
Read the detailed description
In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
Patients are randomized to receive either placebo or paromomycin for 3 weeks. After the initial double-blind phase, all patients receive open-label paromomycin for 3 weeks. Following 6 weeks of therapy, patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks, while complete responders continue receiving the original dose for an additional 3 weeks. Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved. Treatment continues for up to 25 weeks total. Patients are followed at weeks 1, 3, 4, 6, 7, and 9, and then at 2-4 week intervals.
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Paromomycin sulfate
- Keywords
- Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Paromomycin
- Medical subject headings
- Cryptosporidiosis, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paromomycin sulfateDrug
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 CryptosporidiosisStudies 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 68 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carey J, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000771
- Sponsor's protocol ID
- ACTG 192
- Other IDs
- 11167
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Hewitt RG, Yiannoutsos CT, Higgs ES, Carey JT, Geiseler PJ, Soave R, Rosenberg R, Vazquez GJ, Wheat LJ, Fass RJ, Antoninievic Z, Walawander AL, Flanigan TP, Bender JF. Paromomycin: no more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trial Group. Clin Infect Dis. 2000 Oct;31(4):1084-92. doi: 10.1086/318155. Epub 2000 Oct 25.
PubMed 11049793
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3
- ClinicalTrials.gov ID
- NCT00000771
- Acronym / sponsor ID
- ACTG 192
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Paromomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 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 effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit.
In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
Detailed description
In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
Patients are randomized to receive either placebo or paromomycin for 3 weeks. After the initial double-blind phase, all patients receive open-label paromomycin for 3 weeks. Following 6 weeks of therapy, patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks, while complete responders continue receiving the original dose for an additional 3 weeks. Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved. Treatment continues for up to 25 weeks total. Patients are followed at weeks 1, 3, 4, 6, 7, and 9, and then at 2-4 week intervals.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Antiretroviral therapy.
- Macrolides for disseminated Mycobacterium avium.
- Atovaquone for toxoplasmosis.
- Other antimicrobials for concurrent infections.
- Lomotil, Imodium, or deodorized opium tincture in a standardized regimen for diarrhea.
Key exclusion criteria (18 listed)
- Hypersensitivity to aminoglycosides.
- Inability to swallow capsules.
- Active infection due to other enteric pathogens. Previous diagnosis of CMV or MAC infection permitted if patient is currently stabilized on a therapeutic regimen (clarithromycin up to 500 mg bid or azithromycin up to 600 mg daily).
- Other known causes for diarrhea (e.g., malabsorption syndrome, gastrointestinal Kaposi's sarcoma).
- Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum).
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 |
|---|---|---|
| Paromomycin sulfate | 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 4 Nov 2021.
- Background: PubMed 11049793Hewitt RG, Yiannoutsos CT, Higgs ES, Carey JT, Geiseler PJ, Soave R, Rosenberg R, Vazquez GJ, Wheat LJ, Fass RJ, Antoninievic Z, Walawander AL, Flanigan TP, Bender JF. Paromomycin: no more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trial Group. Clin Infect Dis. 2000 Oct;31(4):1084-92. doi: 10.1086/318155. Epub 2000 Oct 25.
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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.
Carey J study chair
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paromomycin sulfate in people with Cryptosporidiosis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 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 10 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 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 NCT00000771, 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 4 Nov 2021.