CryptosporidiosisPhase 1NCT00000980
A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea
A Phase 1 study testing Spiramycin in people with Cryptosporidiosis and HIV Infections, run by Rhone-Poulenc Rorer at 7 sites in United States.
Trial summary
To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea. Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. 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?
- Spiramycin
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- Start not givento not given
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Vitamin supplements.
- Zidovudine (AZT) for patients previously taking AZT. However, dosing with spiramycin should be delayed until the dose of AZT has stabilized. The dose may be decreased for AZT-associated toxicity.
- Allowed for diarrhea:
- Loperamide hydrochloride capsules (2 mg) or loperamide hydrochloride liquid (1 mg/5 ml).
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- Allowed for nausea:
- Sucralfate and metoclopramide hydrochloride.
- Allowed for vomiting:
- Prochlorperazine and trimethobenzamide hydrochloride.
- Allowed as prophylaxis for Pneumocystis carinii pneumonia (PCP):
- Aerosolized pentamidine.
- Patients must have:
- A diagnosis of AIDS according to the CDC.
- Chronic diarrhea.
- Presence of Cryptosporidium oocysts in stool specimen. Patients or a legally authorized representative must sign an informed consent form. Diet will be lactose free, maximum 7 g fat/day with unlimited calorie intake. Patients who require total parenteral nutrition will also be allowed oral intake.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Grade 4 (for hematologic) or Grade 3 (for all other) toxicity.
- Known sensitivity to macrolide antibiotics.
- Presence of other diarrhea-causing pathogens.
- Active opportunistic infection requiring systemic antimicrobial therapy.
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- Toxicity grades according to NIAID toxicity scale for adults.
- Concurrent Medication:
- Excluded:
- Other investigational drugs.
- Cancer chemotherapy.
- Alpha interferon.
- Other immunomodulating agents.
- Other macrolide antibiotics.
- Trimethoprim / sulfamethoxazole.
- Ganciclovir.
- H2 blockers and AL-721.
- Medications known to cause gastrointestinal irritation or alteration of gastrointestinal motility or absorption should be avoided if possible.
- Zidovudine (AZT) therapy may not be initiated and the dose may not be increased during the study.
- Patients with the following are excluded:
- Grade 4 (for hematologic) or Grade 3 (for all other) toxicity.
- Known sensitivity to macrolide antibiotics.
- Presence of other diarrhea-causing pathogens.
- Active opportunistic infection requiring systemic antimicrobial therapy.
- Toxicity grades according to NIAID toxicity scale for adults.
- Prior Medication:
- Excluded within 7 days of study entry:
- Investigational drugs.
- Excluded within 14 days of study entry:
- Cancer chemotherapy.
- Alpha interferon.
- Other immunomodulating agents.
- Other macrolide antibiotics.
- Trimethoprim / sulfamethoxazole.
- Ganciclovir.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
Nelson Tebedo Community Clinic
Dallas, Texas, 75219
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Cornell Univ Med Ctr
New York, New York, 10021
Kaiser Permanente Med Ctr
San Diego, California, 92120
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
About this study
Official title: Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea
To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea.
Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.
Read the detailed description
Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.
Patients are observed for 3 days to establish baseline conditions. They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo; they are not told which 6-day period they receive placebo. All patients receive 15 days of spiramycin. Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days. Responders at either dose are followed weekly for 4 weeks. Should a relapse occur, patients receive an additional 15 days of therapy, at the dose of spiramycin that initially produced a response, following reestablishment of a baseline with 6 days of placebo. Nonresponders to the higher dose are taken off the study.
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Spiramycin
- Keywords
- Single-Blind Method, Spiramycin, AIDS-Related Opportunistic Infections, Injections, Intravenous, Cryptosporidiosis, Diarrhea, Drug Evaluation, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Cryptosporidiosis, HIV Infections, AIDS-Related Opportunistic Infections, Diarrhea, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpiramycinDrug
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.
- Other trials for CryptosporidiosisStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Rhone-Poulenc Rorer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- R Soave, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000980
- Sponsor's protocol ID
- ACTG 113
- Other IDs
- FDA 28A, CCB-301
- Status last verified
- Oct 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea
- ClinicalTrials.gov ID
- NCT00000980
- Acronym / sponsor ID
- ACTG 113
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- Single-Blind Method, Spiramycin, AIDS-Related Opportunistic Infections, Injections, Intravenous, Cryptosporidiosis, Diarrhea, Drug Evaluation, Acquired Immunodeficiency Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Rhone-Poulenc RorerIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- 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 and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea.
Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.
Detailed description
Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.
Patients are observed for 3 days to establish baseline conditions. They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo; they are not told which 6-day period they receive placebo. All patients receive 15 days of spiramycin. Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days. Responders at either dose are followed weekly for 4 weeks. Should a relapse occur, patients receive an additional 15 days of therapy, at the dose of spiramycin that initially produced a response, following reestablishment of a baseline with 6 days of placebo. Nonresponders to the higher dose are taken off the study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Vitamin supplements.
- Zidovudine (AZT) for patients previously taking AZT. However, dosing with spiramycin should be delayed until the dose of AZT has stabilized. The dose may be decreased for AZT-associated toxicity.
- Loperamide hydrochloride capsules (2 mg) or loperamide hydrochloride liquid (1 mg/5 ml).
- Sucralfate and metoclopramide hydrochloride.
- Prochlorperazine and trimethobenzamide hydrochloride.
Key exclusion criteria (35 listed)
- Grade 4 (for hematologic) or Grade 3 (for all other) toxicity.
- Known sensitivity to macrolide antibiotics.
- Presence of other diarrhea-causing pathogens.
- Active opportunistic infection requiring systemic antimicrobial therapy.
- Toxicity grades according to NIAID toxicity scale for adults.
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 |
|---|---|---|
| Spiramycin | 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.
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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.
R Soave study chair
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spiramycin in people with Cryptosporidiosis and HIV Infections, run by Rhone-Poulenc Rorer at 7 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 16 inclusion and 35 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 7 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 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?
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.