Completed
Evaluation of the Interaction Between High Dose Trimethoprim/Sulfamethoxazole and Zidovudine
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here