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The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primaquine
Clindamycin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Primaquine, Infusions, Intravenous, Drug Evaluation, Drug Therapy, Combination, Administration, Oral, Acquired Immunodeficiency Syndrome, Clindamycin

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Oral antiemetics. Patients must have the following for inclusion: HIV positive by ELISA, p24 antigen or culture. Pneumocystis carinii pneumonia (PCP). Patients must have an (A-a) DO2 < 40 mmHg on room air. Willingness to sign an informed consent. Prior Medication: Allowed: - Prophylaxis for Pneumocystis carinii pneumonia (PCP) with agents other than clindamycin and primaquine. Exclusion Criteria Concurrent Medication: Excluded: Hematotoxic therapy, including zidovudine (AZT) or ganciclovir. Patients with the following are excluded: History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs. Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality. Concomitant conditions defined in Patient Exclusion Co-Existing Conditions. Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study. Note: Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry. Prior Medication: Excluded within 14 days of study entry: Systemic steroids at doses exceeding physiologic replacement or other investigational agents. Excluded within 6 weeks of study entry: Prior institution of any antiprotozoal therapy for the current episode of Pneumocystis carinii pneumonia or prophylaxis. Patients must not have any of the following symptoms or diseases: History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs. Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality. Diarrhea, defined as = or > 3 watery stools per day. Severe nausea and vomiting or other medical condition, such as ileus, that precludes oral therapy. Ventilator dependence or (A-a) DO2 = > 30 mm Hg. Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study. Note: Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • San Francisco AIDS Clinic / San Francisco Gen Hosp
  • Northwestern Univ Med School
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Indiana Univ Hosp
  • Univ Hosp of Cleveland / Case Western Reserve Univ
  • Ohio State Univ Hosp Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 18, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000717
Brief Title
The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS
Official Title
The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1991 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To determine the safety and effectiveness of clindamycin and primaquine in the treatment of mild Pneumocystis carinii pneumonia (PCP) in AIDS patients. As many as 80 percent of AIDS patients experience at least one episode of PCP and about one-third of these patients have a recurrence of the disease. Drugs currently used for treatment of acute PCP are toxic to the majority of AIDS patients. The combination of clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been used safely in humans for treatment of other diseases. It is possible that the combination may prove to be as good or better than standard therapy for PCP and side effects may be less.
Detailed Description
As many as 80 percent of AIDS patients experience at least one episode of PCP and about one-third of these patients have a recurrence of the disease. Drugs currently used for treatment of acute PCP are toxic to the majority of AIDS patients. The combination of clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been used safely in humans for treatment of other diseases. It is possible that the combination may prove to be as good or better than standard therapy for PCP and side effects may be less. The proposal for the first 20 patients enrolled in ACTG 044 initially called for an open-labelled, pilot study of intravenous (IV) clindamycin and primaquine therapy in patients with mild to moderate PCP. Preliminary results of the first 22 patients entered into ACTG 044 indicate that the response rate to therapy was over 90 percent. The rate of discontinuation secondary to toxic side effects was only 20 percent. Additional uncontrolled studies have shown an excellent clinical response and safety profile in another 60 patients. The protocol has been amended to provide an all oral dosing regimen. An additional 20 patients with mild PCP will be enrolled and tested with oral clindamycin and primaquine on an outpatient basis. All patients will receive clindamycin and primaquine. Total duration of therapy will be 21 days. Patients may be hospitalized at any time during the study as clinically indicated. Treatment with zidovudine may be started or resumed after completion of clindamycin / primaquine therapy. AMENDED: An additional 30 patients instead of 20 patients with mild PCP will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Primaquine, Infusions, Intravenous, Drug Evaluation, Drug Therapy, Combination, Administration, Oral, Acquired Immunodeficiency Syndrome, Clindamycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Primaquine
Intervention Type
Drug
Intervention Name(s)
Clindamycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Oral antiemetics. Patients must have the following for inclusion: HIV positive by ELISA, p24 antigen or culture. Pneumocystis carinii pneumonia (PCP). Patients must have an (A-a) DO2 < 40 mmHg on room air. Willingness to sign an informed consent. Prior Medication: Allowed: - Prophylaxis for Pneumocystis carinii pneumonia (PCP) with agents other than clindamycin and primaquine. Exclusion Criteria Concurrent Medication: Excluded: Hematotoxic therapy, including zidovudine (AZT) or ganciclovir. Patients with the following are excluded: History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs. Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality. Concomitant conditions defined in Patient Exclusion Co-Existing Conditions. Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study. Note: Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry. Prior Medication: Excluded within 14 days of study entry: Systemic steroids at doses exceeding physiologic replacement or other investigational agents. Excluded within 6 weeks of study entry: Prior institution of any antiprotozoal therapy for the current episode of Pneumocystis carinii pneumonia or prophylaxis. Patients must not have any of the following symptoms or diseases: History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs. Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality. Diarrhea, defined as = or > 3 watery stools per day. Severe nausea and vomiting or other medical condition, such as ileus, that precludes oral therapy. Ventilator dependence or (A-a) DO2 = > 30 mm Hg. Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study. Note: Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Black JR
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Univ Hosp of Cleveland / Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2060532
Citation
Black JR, Feinberg J, Murphy RL, Fass RJ, Carey J, Sattler FR. Clindamycin and primaquine as primary treatment for mild and moderately severe Pneumocystis carinii pneumonia in patients with AIDS. Eur J Clin Microbiol Infect Dis. 1991 Mar;10(3):204-7. doi: 10.1007/BF01964465.
Results Reference
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PubMed Identifier
8086551
Citation
Black JR, Feinberg J, Murphy RL, Fass RJ, Finkelstein D, Akil B, Safrin S, Carey JT, Stansell J, Plouffe JF, et al. Clindamycin and primaquine therapy for mild-to-moderate episodes of Pneumocystis carinii pneumonia in patients with AIDS: AIDS Clinical Trials Group 044. Clin Infect Dis. 1994 Jun;18(6):905-13. doi: 10.1093/clinids/18.6.905.
Results Reference
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The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS

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