A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS
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| ClinicalTrials.gov Identifier: NCT00000640 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : March 30, 2012
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To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP.
The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia, Pneumocystis Carinii HIV Infections | Drug: Primaquine Drug: Sulfamethoxazole-Trimethoprim Drug: Dapsone Drug: Clindamycin | Phase 3 |
The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
Patients with confirmed PCP are randomized into one of three treatment groups. Group A receives SMX/TMP. Half of group A receives dapsone placebo (placebo is an inactive substance) daily plus trimethoprim placebo; the other half receives clindamycin placebo plus primaquine placebo. Group B is given dapsone plus trimethoprim. Half of group B receives SMX/TMP placebo; the other half receives clindamycin placebo plus primaquine placebo. Group C is given clindamycin plus primaquine. Half of group C receives SMX/TMP placebo, the other half receives dapsone placebo plus trimethoprim placebo. Treatment lasts 21 days; dosages will be adjusted for patients weighing less than 50 kg and more than 80 kg. Patients with a history of intolerance to SMX/TMP for whom rechallenge is considered medically contraindicated may be randomized to one of the non-sulfamethoxazole-containing arms.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 290 participants |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Trimethoprim / Sulfamethoxazole in the Treatment of Mild-to-Moderate PCP in Patients With AIDS |
| Actual Study Completion Date : | September 1994 |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Erythropoietin.
- Maintenance treatment with investigational triazoles (e.g., itraconazole).
- Antiemetics for nausea/vomiting, antihistamines for rash/pruritus, antipyretics for systemic symptoms (fever, headache, etc.) should be used for treatment of symptoms.
- Nonsteroidal antiinflammatory agents may be used for control of myalgias, headache, etc.
Concurrent Treatment:
Allowed:
- Blood transfusions.
Patients must have the following:
- Pneumocystis carinii pneumonia.
- HIV infection.
- Willing and able to sign informed consent. Patients under 18 years of age may enter with consent of parent or guardian.
Prior Medication:
Allowed:
- Up to 24 hours of treatment with sulfamethoxazole/trimethoprim (SMX/TMP), dapsone / trimethoprim, or clindamycin / primaquine, or one dose of pentamidine for this episode of Pneumocystis carinii pneumonia (PCP).
- Prior PCP prophylaxis.
Required:
- Adjunctive prednisone therapy in patients with (A-a) DO2 of 35 - 45 torr receiving acute anti-PCP treatment.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and diseases are excluded:
Positive screen for glucose-6-phosphate dehydrogenase deficiency.
- Known NAD methemoglobin reductase deficiency and/or known hemoglobin M abnormality.
Concurrent Medication:
Excluded:
- Zidovudine (AZT).
- Ganciclovir.
- GM-CSF or G-CSF. Rifampin.
- Rifabutin.
- Corticosteroids (in patients with baseline (A-a) DO2 < 35 torr). Investigational drugs not specifically allowed.
- Folinic acid.
Patients with the following are excluded:
- Previous dose-limiting intolerance to sulfones, trimethoprim, clindamycin, or primaquine.
Requirement for other medications potentially effective in the treatment of Pneumocystis carinii pneumonia (PCP) (e.g., pyrimethamine and sulfadiazine).
- Prior enrollment in ACTG 108. Presence of other concurrent pulmonary pathology that would make interpretation of response to antipneumocystis therapy difficult.
Inability to take oral therapy.
Prior Medication:
Excluded:
- Acute treatment doses of anti-Pneumocystis carinii pneumonia agents within 30 days prior to study entry except as noted above.
- Systemic steroids above adrenal replacement doses within 7 days prior to study entry (except for patients with (A-a) DO2 of 35 - 45 torr who receive prednisone in conjunction with acute anti-PCP treatment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000640
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| Study Chair: | Safrin S | ||
| Study Chair: | Black JR |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000640 |
| Other Study ID Numbers: |
ACTG 108 11083 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | March 30, 2012 |
| Last Verified: | March 2012 |
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Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Primaquine Dapsone |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Clindamycin Sulfamethoxazole-Trimethoprim |
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Pneumonia, Pneumocystis Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Clindamycin Clindamycin palmitate Clindamycin phosphate Dapsone Trimethoprim, Sulfamethoxazole Drug Combination Primaquine Trimethoprim |
Sulfamethoxazole Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents, Urinary Renal Agents Folic Acid Antagonists Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors |