|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000734 |
Purpose
To determine if the pharmacokinetics of high 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 when trimethoprim/sulfamethoxazole (SMX/TMP) is given at the same time, or whether the pharmacokinetics of SMX/TMP is altered by AZT given at the same time.
AZT has been effective in treating HIV infection in some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP). 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 |
|---|---|
|
HIV Infections |
Drug: Sulfamethoxazole-Trimethoprim Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Evaluation of the Interaction Between High Dose Trimethoprim/Sulfamethoxazole and Zidovudine |
| Estimated Enrollment: | 10 |
AZT has been effective in treating HIV infection in some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP). 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 with HIV infection take AZT every 4 hours and/or SMX/TMP every 8 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.
Eligibility| 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
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 30 days of study entry:
Contacts and Locations
More Information
| Study ID Numbers: | ACTG 037 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000734 History of Changes |
| Health Authority: | United States: Federal Government |
|
Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Drug Interactions Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Sulfamethoxazole-Trimethoprim |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Trimethoprim Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Trimethoprim-Sulfamethoxazole Combination Infection Renal Agents Reverse Transcriptase Inhibitors Antimalarials Antiparasitic Agents |
Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Sulfamethoxazole Acquired Immunodeficiency Syndrome Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions |