Pneumonia, Pneumocystis CariniiPhase 4NCT00000816
Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
A Phase 4 study testing Sulfamethoxazole-Trimethoprim in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in 3 countries.
Trial summary
To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients. 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?
- Sulfamethoxazole-Trimethoprim
- How many people
- 370 participants
- Where
- 42 sitesin 3 countries
- Study dates
- Start not givento Sep 1996
- Phase
- Phase 4
- 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 if clinically indicated:
- Recombinant erythropoietin (rEPO) and G-CSF.
- Allowed for symptomatic treatment of mild study drug toxicity:
- Antipyretics and analgesics (ibuprofen).
- Antihistamines (diphenhydramine HCl).
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- Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use).
- Systemic steroids.
- Patients must have:
- HIV infection.
- CD4 count <= 250 cells/mm3 OR history or presence of thrush.
- No history of confirmed or probable pneumocystosis.
- NOTE:
- Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment.
- This study is appropriate for prisoner participation.
- Coenrollment in ongoing ACTG antiretroviral studies is permitted provided no new study drugs are added to the patient's drug regimen for 4 weeks before or after initiation of SMX/TMP.
- Prior Medication:
- Allowed:
- Prior aerosolized pentamidine and dapsone for primary PCP prophylaxis.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known adverse reactions to sulfa, trimethoprim, or SMX/TMP.
- Inability to comply with dosing schedule or complete dosing record.
- Concurrent Medication:
- Excluded:
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- Procysteine.
- Glutathione.
- N-acetylcysteine (NAC).
- Antihistamines (unless used for symptomatic treatment of study drug toxicity).
- Systemic corticosteroids (unless used for replacement purposes).
- Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity).
- TMP or sulfa drugs outside of the study.
- Prior Medication:
- Excluded at any time:
- Prior SMX/TMP as primary PCP prophylaxis.
- Excluded within 4 weeks prior to study entry:
- Initiation of antiretroviral agents.
- Initiation of anti-infective agents (including SMX/TMP for another indication).
- Excluded within 2 weeks prior to study entry:
- Antihistamines.
- Procysteine.
- Glutathione.
- N-acetylcysteine (NAC).
- Systemic corticosteroids (unless used for replacement purposes).
- Leucovorin calcium.
- TMP and sulfa drugs separately.
Trial locations and contacts
42 sites in 3 countries.
42 sites in 3 countries
United States40 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Bmc Actg Crs
Boston, Massachusetts, 02118
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Unc Aids Crs
Chapel Hill, North Carolina, 27599
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, 28203
Northwestern University CRS
Chicago, Illinois, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
MetroHealth CRS
Cleveland, Ohio, 44109
Case CRS
Cleveland, Ohio
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, 27401
Queens Med. Ctr.
Honolulu, Hawaii, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
USC CRS
Los Angeles, California, 90033
Univ. of Miami AIDS CRS
Miami, Florida, 33136
Hennepin County Med. Ctr., Div. of Infectious Diseases
Minneapolis, Minnesota, 55415
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10029
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 68198
Stanford CRS
Palo Alto, California, 94305
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York
Ucsf Aids Crs
San Francisco, California, 94110
Santa Clara Valley Med. Ctr.
San Jose, California
San Mateo County AIDS Program
San Mateo, California
University of Washington AIDS CRS
Seattle, Washington, 98122
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Washington U CRS
St Louis, Missouri
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502
About this study
Official title: Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis
To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Read the detailed description
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Being tested
- Sulfamethoxazole-Trimethoprim
- Keywords
- Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Sulfamethoxazole-Trimethoprim
- 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.
Sulfamethoxazole-TrimethoprimDrug
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 (2)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 4
- Primary purpose
- Treatment
- Enrolment
- 370 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Responsible party
- Sponsor
- Investigators
- Para MF, Study chairDohn MN, Study chairFrame P, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000816
- Sponsor's protocol ID
- ACTG 268
- Other IDs
- 11244
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Para MF, Dohn M, Frame P, Becker S, Finkelstein D, Walawander A. ACTG 268 trial - gradual initiation of trimethoprim/sulfamethoxazole (T/S) as primary prophylaxis for Pneumocystis carinii pneumonia (PCP). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:65 (abstract no 2)
Para MF, Finkelstein D, Becker S, Dohn M, Walawander A, Black JR. Reduced toxicity with gradual initiation of trimethoprim-sulfamethoxazole as primary prophylaxis for Pneumocystis carinii pneumonia: AIDS Clinical Trials Group 268. J Acquir Immune Defic Syndr. 2000 Aug 1;24(4):337-43. doi: 10.1097/00126334-200008010-00007.
PubMed 11015150
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
- Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis
- ClinicalTrials.gov ID
- NCT00000816
- Acronym / sponsor ID
- ACTG 268
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Sulfamethoxazole-Trimethoprim
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- 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 whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Detailed description
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.
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 (19 listed)
- Recombinant erythropoietin (rEPO) and G-CSF.
- Antipyretics and analgesics (ibuprofen).
- Antihistamines (diphenhydramine HCl).
- Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use).
- Systemic steroids.
Key exclusion criteria (27 listed)
- Known adverse reactions to sulfa, trimethoprim, or SMX/TMP.
- Inability to comply with dosing schedule or complete dosing record.
- Procysteine.
- Glutathione.
- N-acetylcysteine (NAC).
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 |
|---|---|---|
| Sulfamethoxazole-Trimethoprim | 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.
- BackgroundPara MF, Dohn M, Frame P, Becker S, Finkelstein D, Walawander A. ACTG 268 trial - gradual initiation of trimethoprim/sulfamethoxazole (T/S) as primary prophylaxis for Pneumocystis carinii pneumonia (PCP). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:65 (abstract no 2)
- Background: PubMed 11015150Para MF, Finkelstein D, Becker S, Dohn M, Walawander A, Black JR. Reduced toxicity with gradual initiation of trimethoprim-sulfamethoxazole as primary prophylaxis for Pneumocystis carinii pneumonia: AIDS Clinical Trials Group 268. J Acquir Immune Defic Syndr. 2000 Aug 1;24(4):337-43. doi: 10.1097/00126334-200008010-00007.
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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.
Para MF study chair
Dohn MN study chair
Frame P study chair
42 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfamethoxazole-Trimethoprim in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in 3 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 19 inclusion and 27 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 42 sites in United States, Puerto Rico, Tanzania. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 NCT00000816, which also lists 2 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 4 Nov 2021.