Search / Trial NCT00000734

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of November 14, 2024

Completed

Keywords

Trimethoprim Sulfamethoxazole Combination Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Drug Interactions Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Sulfamethoxazole Trimethoprim

ClinConnect Summary

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 o...

Gender

ALL

Eligibility 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.

Trial Officials

Ptachcinski R

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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