Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Sulfamethoxazole-Trimethoprim (Drug); Zidovudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Ptachcinski R, Study Chair
Summary
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.
Clinical Details
Official title: Evaluation of the Interaction Between High Dose Trimethoprim/Sulfamethoxazole and Zidovudine
Study design: Treatment, Open Label
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
Prior Medication:
Allowed:
- Zidovudine (AZT) for patients with AIDS.
- AIDS related complex (ARC). The presence of any one of the following findings within
12 months prior to entry and the absence of a concurrent illness or condition other
than HIV infection to explain the findings:
- Fever of > 38. 5 degrees C persisting for longer than 3 weeks.
- Involuntary weight loss of > 15 lbs. or > 10 percent of baseline noted in a 120-day
period prior to evaluation.
- Diarrhea (> 2 liquid stools per day) persisting for longer than 1 month.
- History of clinical diagnosis of oral candidiasis or hairy leukoplakia.
- Patients who have AIDS-associated opportunistic infections or tumors.
- Patients eligible for AZT under the labeling.
- A positive HIV antibody test. Exceptions will be made for patients with a previously
positive HIV antibody test with progressive disease and patients where virus isolation
has been made.
- Patient with stable Kaposi's sarcoma, mild herpes infection, mild or stable
depression, asymptomatic or mild cytomegalovirus or Epstein-Barr virus infection, or a
hepatitis B virus carrier state will be acceptable for study.
- A life expectancy of at least 3 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Severe ongoing opportunistic infections including Pneumocystis carinii pneumonia
(PCP), cryptococcal or toxoplasmosis meningo-encephalitis, disseminated herpes simplex
or herpes zoster.
- Significant diarrhea at entry ( > 1 watery stool per day).
Concurrent Medication:
Excluded:
- Phenytoin.
Prior Medication:
Excluded within 30 days of study entry:
- Other antiretroviral agents or immunomodulating agents.
- Patient has demonstrated prior sensitivity or has experienced significant adverse
effects during prior therapy with the drugs to be used in the study.
- Patient cannot abstain from alcohol or any other drugs, including nonprescription
medication, during the study period.
Locations and Contacts
Univ of Pittsburgh Med School, Pittsburgh, Pennsylvania, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Sulfamethoxazole-Trimethoprim
Related publications: Canas E, Pachon J, Viciana P, Garcia-Pesquera F, Castillo JR, Jimenez-Mejias ME. Effect of trimethoprim-sulphamethoxazole on zidovudine kinetics in HIV infected patients. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:168
Last updated: June 23, 2005
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