Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Evaluation of the Interaction Between High Dose Trimethoprim/Sulfamethoxazole and Zidovudine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Univ of Pittsburgh Med School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Ptachcinski R

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

May 1, 1990

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 037
  • 11013 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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