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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000727 |
Purpose
To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth, and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary HIV infection.
AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate.
The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate Drug: Pyrimethamine Drug: Sulfamethoxazole/Trimethoprim Drug: Sulfadoxine/Pyrimethamine Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Controlled Comparative Trial of Trimethoprim - Sulfamethoxazole Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) |
| Estimated Enrollment: | 322 |
AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate.
The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone.
Patients receive the standard dose of AZT at study entry. Low body weight patients receive AZT at a lower dose. Patients are randomly assigned to one of two medications intended to prevent the recurrence of PCP. Patients assigned to SMX/TMP will take 1 capsule which contains both drugs once a day for 1 year. Patients assigned to PEN will have 1 aerosol treatment every 4 weeks for 1 year. Blood will be drawn at intervals in order to estimate blood levels of the drugs and to detect any adverse effects from the drugs. Note: Earlier versions of this protocol reflect its original design as a 3-arm study comparing aerosolized PEN, SMX/TMP, and pyrimethamine-sulfadoxine as secondary prophylaxis of PCP in AIDS patients receiving AZT. In order to reduce the effective sample size and permit the completion of accrual in a reasonable period of time, the pyrimethamine - sulfadoxine arm of this study has been discontinued. Patients randomized to this arm will be continued in this study on the original randomized therapy. Management of these patients will follow that described for SMX/TMP in the latest protocol version. AMENDED: Lower dose of AZT allowed.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must fulfill the following criteria:
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Prior Medication:
Allowed:
Risk Behavior:
Allowed:
Exclusion Criteria
Concurrent Medication:
Excluded:
Prior Medication:
Excluded for the 30 patients who will undergo pharmacokinetic studies:
Prior Treatment:
Excluded within 2 weeks of study entry:
Patients may not have any of the following symptoms or diseases:
Contacts and Locations
Hide Study Locations| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Stanford Private Practice | |
| Redwood City, California, United States | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Stanford Univ School of Medicine | |
| Stanford, California, United States, 94305 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Palo Alto Veterans Adm Med Ctr / Stanford Univ | |
| Palo Alto, California, United States, 94304 | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| SUNY - Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Beth Israel Med Ctr / Peter Krueger Clinic | |
| New York, New York, United States, 10003 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| Holmes Hosp / Univ of Cincinnati Med Ctr | |
| Cincinnati, Ohio, United States, 452670405 | |
| Univ Hosp of Cleveland / Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Milton S Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| West Penn Hosp | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Saint Francis' Med Ctr | |
| Pittsburgh, Pennsylvania, United States, 15201 | |
| Shadyside Hosp | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Homestead Private Office | |
| Homestead, Pennsylvania, United States, 15120 | |
| Presbyterian Univ Hosp | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Univ of Pittsburgh Med School | |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98105 | |
| Study Chair: | Holzman R | |
| Study Chair: | Hardy WD |
More Information
| Study ID Numbers: | ACTG 021 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000727 History of Changes |
| Health Authority: | United States: Federal Government |
|
Sulfadoxine Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Pyrimethamine |
Drug Evaluation Administration, Inhalation Administration, Oral Aerosols Acquired Immunodeficiency Syndrome Zidovudine |
|
Antimetabolites Pyrimethamine Trypanocidal Agents Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Sexually Transmitted Diseases, Viral Trimethoprim Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Trimethoprim-Sulfamethoxazole Combination Renal Agents Infection Reverse Transcriptase Inhibitors |
Antimalarials Pneumonia, Pneumocystis Mycoses Antiparasitic Agents Anti-Retroviral Agents Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Antifungal Agents Pentamidine Retroviridae Infections Nucleic Acid Synthesis Inhibitors Lung Diseases, Fungal RNA Virus Infections Anti-HIV Agents |
