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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000732 |
To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT reaches the blood, what concentration of AZT is attained in the blood, and how long AZT remains in the blood) changes from day-to-day in the same patient. Also to determine whether the pharmacokinetics of AZT is changed by sulfamethoxazole/trimethoprim (SMX/TMP) given at the same time or whether the pharmacokinetics of SMX/TMP is altered by AZT therapy. AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an important cause of disease and death in patients with AIDS. It is important to know how drugs interact in patients because addition of a second drug may change the speed at which a drug is eliminated from the body, and cause increased toxic effects or decreased therapeutic effects.
Condition | Intervention |
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HIV Infections |
Drug: Sulfamethoxazole-Trimethoprim Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Evaluation of the Interaction Between Low Dose Trimethoprim/Sulfamethoxazole and Zidovudine |
Estimated Enrollment: | 10 |
AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an important cause of disease and death in patients with AIDS. It is important to know how drugs interact in patients because addition of a second drug may change the speed at which a drug is eliminated from the body, and cause increased toxic effects or decreased therapeutic effects.
Patients take AZT every 4 hours and/or SMX/TMP every 12 hours by mouth for 4 days as outpatients and then come into the clinical research center for 2 days of studies. On day 5 the final dose of medicine is given orally (SMX/TMP) or by intravenous infusion (AZT). Blood samples are drawn 10-20 times over a period of 12 hours and urine is collected for 36 hours. Concentrations of the drugs in the blood and urine samples are determined. This sequence is repeated twice, so that each patient takes AZT alone, SMX/TMP alone, and the combination of AZT and SMX/TMP over a period of about 3 weeks. Patients may be included in the study if they are asymptomatic, or have been diagnosed with ARC or AIDS, but not if they have PCP or any other severe opportunistic infection.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Prior Medication:
Allowed:
Exclusion Criteria
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 30 days of study entry:
Study ID Numbers: | ACTG 033 |
Study First Received: | November 2, 1999 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00000732 |
Health Authority: | United States: Federal Government |
Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Drug Interactions Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Sulfamethoxazole-Trimethoprim |
Sexually Transmitted Diseases, Viral Trimethoprim Sulfamethoxazole Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Trimethoprim-Sulfamethoxazole Combination Immunologic Deficiency Syndromes |
Folic Acid Virus Diseases Pneumonia, Pneumocystis HIV Infections Sexually Transmitted Diseases Retroviridae Infections Pneumonia |
Antimetabolites Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists |
Infection Renal Agents Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Antimalarials Antiparasitic Agents Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |