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Clindamycin with Primaquine Vs. Trimethoprim-Sulfamethoxazole

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Clindamycin with Primaquine Vs. Trimethoprim-Sulfamethoxazole 524 Clindamycin with Primaquine vs. Trimethoprim-Sulfamethoxazole Therapy for Mild and Moderately Severe Pneumocystis carinii Pneumonia in Patients with AIDS: A Multicenter, Double-Blind, Randomized Trial (CTN 004) Emil Toma, Anona Thorne, Joel Singer, Janet Raboud, From the Department of Microbiology and Infectious Diseases, Centre Claude Lemieux, Sylvie Trottier, Michel G. Bergeron, Hospitalier de l'Universite de MontreÂal, the Immunode®ciency Chris Tsoukas, Julian Falutz, Richard Lalonde, Treatment Centre (IDTC), Montreal General Hospital, and the Royal Victoria Hospital, Montreal, and Centre Hospitalier de l'Universite du Christiane Gaudreau, Rachel Therrien, and the QueÂbec, Quebec, Quebec; and the Canadian HIV Trials Network, CTN-PCP Study Group* Vancouver, British Columbia, Canada This double-blind, randomized, multicenter trial compared clindamycin/primaquine (Cm/Prq) Downloaded from https://academic.oup.com/cid/article/27/3/524/280761 by guest on 25 September 2021 with trimethoprim-sulfamethoxazole (TMP-SMZ) as therapy for AIDS-related Pneumocystis carinii pneumonia (PCP). Forty-®ve patients received clindamycin (450 mg four times daily [q.i.d.]) and primaquine (15 mg of base/d); 42 received TMP-SMZ (320 mg/1,600 mg q.i.d. if weight of §60 kg or 240 mg/1,200 mg q.i.d. if weight of õ60 kg) plus placebo primaquine. Overall, the ef®cacy of Cm/Prq was similar to that of TMP-SMZ (success rate, 76% vs. 79%, respectively); Cm/Prq was associated with fewer adverse events (P Å .04), less steroid use (P Å .18), and more rashes (P Å .07). These differences were even greater for patients with PaO2 of ú70 mm Hg (P Å .02, P Å .04, and P Å .02, respectively). For patients with PaO2 of £70 mm Hg (23 Cm/Prq recipients and 21 TMP-SMZ recipients), the ef®cacy of Cm/Prq was similar to that of TMP-SMZ (success rate, 74% vs. 76%, respectively); Cm/Prq was associated with similar adverse events (P Å .57), steroid use (P Å .74), and rashes (P Å .78). This trial con®rms that Cm/Prq is a reasonable alternative therapy for mild and moderately severe PCP. The implementation of effective prophylaxis for Pneumo- have been evaluated in open, noncontrolled [11±13], retrospec- cystis carinii pneumonia (PCP) as well as earlier diagnosis and tive [14, 15], prospective, noncomparative [16], and double- treatment of HIV infection have contributed to a decline in its blind, randomized trials [17, 18]. No statistically signi®cant incidence [1±3]. Nonetheless, PCP remains the most frequent differences in therapeutic ef®cacy, survival, or rates of dose- AIDS-de®ning disease, and severe forms are still encountered limiting toxicities have been detected. [1±4]. Patients experiencing adverse events associated with The initial aim of this prospective, double-blind, randomized conventional agents during prophylaxis or therapy for PCP as trial was to assess the safety and ef®cacy of Cm/Prq in compari- well as those for whom standard therapeutic regimens fail re- son with trimethoprim-sulfamethoxazole (TMP-SMZ) as ther- quire alternative therapy, such as dapsone/trimethoprim or ato- apy for mild but also moderately severe forms of AIDS-related vaquone for mild-to-moderate PCP and trimetrexate with PCP. folinic acid for moderately severe PCP [4±9]. The action of clindamycin/primaquine (Cm/Prq) against P. carinii was ®rst proven in 1987 in tissue cultures and in an Patients and Methods experimental rat model [10]. Since then, its safety and ef®cacy Study Design and Treatment Regimens This was a double-blind, randomized study conducted Received 7 November 1997; revised 29 April 1998. through the Canadian HIV Trials Network (CTN) in 15 univer- This work was presented in part at the 35th Interscience Conference on sity-af®liated hospitals (see list under CTN-PCP Study Group Antimicrobial Agents and Chemotherapy held on 17±20 September 1995 in San Francisco. Members at the end of the text). An independent data safety Written informed consent was obtained from the patients, and the study was and monitoring board that periodically evaluated the conduct approved by the Canadian HIV Trials Network Safety and Ef®cacy Review of the study recommended its termination 2 years after initia- Committee and by the institutional ethics committees at the participating cen- ters. tion (2 March 1992) because of slow accrual of patients and Financial support: This work was supported by National Health Research a lower-than-expected incidence of clinical end points. and Development Programme (NHRDP)-Health and Welfare Canada (grant Primaquine and an identical placebo were supplied by 6605-3720 AIDS), the Canadian HIV Trials Network, Sano®-Winthrop (USA), Upjohn (Canada), and Burroughs Wellcome (Canada). Sano®-Winthrop (New York). Clindamycin was provided by * Members of the CTN-PCP Study Group are listed at the end of the text. Upjohn (Mississauga, Ontario, Canada), and TMP-SMZ was Reprints or correspondence: Dr. Emil Toma, HoÃtel-Dieu de Montreal, 3840 obtained from Burroughs Wellcome (Kirkland, Quebec, Can- St-Urbain, Montreal, Quebec H2W 1T8, Canada. ada). The preparation of intravenous medications in similar Clinical Infectious Diseases 1998;27:524±30 packages was done by local pharmacies following a central q 1998 by the Infectious Diseases Society of America. All rights reserved. 1058±4838/98/2703±0019$03.00 protocol. Oral clindamycin and TMP-SMZ were packaged in / 9c55$$se20 08-17-98 22:29:49 cidal UC: CID CID 1998;27 (September) Treatment of AIDS-Related PCP 525 similar-looking capsules by Dr. N. McMullen at the Faculty £70 mm Hg at study entry or at any time during the course of Pharmacy, University of Montreal, Montreal. of therapy was decided by the patient's physician [19±21]. To ensure a balanced distribution, randomization was stra- Secondary prophylaxis was recommended to begin 2 weeks ti®ed according to PaO2 measured when patients were breathing after study termination. room air: ú70 mm Hg and 50 to 70 mm Hg. Inclusion criteria were as follows: age of older than 16 years, proven or presump- Clinical and Laboratory Assessments tive HIV-related PCP, PaO2 of ú50 mm Hg, and body weight of ú45 kg. Individuals with allergy or intolerance to the study At baseline, each patient underwent a physical examination, medication, known glucose-6-phosphate dehydrogenase de®- a detailed medical history and chest radiographs were obtained, ciency, grade 3 or more diarrhea or vomiting, or a history and arterial blood gas tension and pH were measured while of pseudomembranous colitis in the previous 2 months were the patient was breathing room air. A complete blood cell count excluded from enrollment. Other exclusion criteria were preg- with differential blood cell counts, blood chemistry analysis, Downloaded from https://academic.oup.com/cid/article/27/3/524/280761 by guest on 25 September 2021 nancy or lactation; active intravenous drug use; inability to urinalysis, lymphocyte immunophenotyping, tests for glucose- attend follow-up visits; administration of more than two doses 6-phosphate dehydrogenase de®ciency (as needed), blood cul- of TMP-SMZ, pentamidine, dapsone/trimethoprim, atova- tures, toxoplasma serology (optional), and a test for serum quone, or Cm/Prq within 3 days preceding initiation of study cryptococcal antigen were performed. Sputum or bronchoal- drug therapy; or concomitant chemotherapy or therapy with veolar lavage ¯uid specimens were processed for the presence systemic corticosteroids, colony-stimulating factors, amphoter- of mycobacteria, fungi, and cytomegalovirus in addition to icin B, ganciclovir, or cyclosporine. Laboratory exclusion crite- P. carinii. The Karnofsky score was assessed, and PCP scores ria were as follows: granulocyte count, õ1,000/dL (1 1 109/L); for body temperature, respiratory rate, cough, chest tightness, hemoglobin level, õ9.0 g/dL (90 g/L); platelet count, dyspnea, need for supplemental O2, and chest radiograph ®nd- õ75,000/dL (75 1 109/L); serum creatinine level, ú1.25 times ings were calculated on the basis of a modi®cation of that the upper limit of normal; and results of liver function tests, ú5 proposed by Nichols et al. [22] and Vanhems and Toma [23]. times the upper limit of normal. During the study period, clinical evaluations and routine The diagnosis of PCP was con®rmed by identi®cation of laboratory investigations (complete blood cell counts and blood P. carinii in specimens of induced or expectorated sputum or chemistry analyses) were performed at days 3, 7, 10, 14, and bronchoalveolar lavage ¯uid. Patients with presumptive PCP 21 of therapy. Repeated chest radiographs were obtained at were withdrawn from the trial if the diagnosis of PCP was not days 7, 14, and 21 of treatment. These assessments were re- proven within 5 days of study entry. The most appropriate peated 2 weeks and 1, 2, 3, and 6 months after termination of treatment was decided by the treating physicians. Attending study treatment or until there was a PCP relapse or the patient physicians, patients, and investigators were blinded to each died, if earlier. Lymphocyte immunophenotyping was repeated patient's study treatment. 2 weeks after termination of study treatment. The ®rst regimen was TMP-SMZ (intravenous or oral) at a dose of 320 mg/1,600 mg (or four capsules if given orally) Evaluation of Safety and Ef®cacy every 6 hours for patients weighing §60 kg and 240 mg/ 1,200 mg (or three capsules if given orally) every 6 hours for Symptoms and signs of toxicity and abnormal laboratory test individuals weighing õ60 kg; in addition, one capsule of pla- results were graded (1 to 4) according to criteria set by the cebo primaquine was given daily. The second regimen con- AIDS Clinical Trials Group of the National Institute of Allergy sisted of clindamycin (intravenous or oral) at a dose of and Infectious Diseases. Grade 3 or 4 toxicity represented an 450 mg every 6 hours and primaquine (oral) at a daily dose indication to discontinue the study treatment, but the ®nal deci- of 15 mg of base.
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