Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine (NCT00000732) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine
United States10 participants
Plain-language summary
To determine if the pharmacokinetics of low 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 by sulfamethoxazole/trimethoprim (SMX/TMP) given at the same time or whether the pharmacokinetics of SMX/TMP is altered by AZT therapy. AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an important cause of disease and death in patients with AIDS. 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 conditions other than HIV infection to explain the findings:
* Fever of \> 38.5 C degrees 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-defining 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.
* A life expectancy of at least 3 months.
* 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.
Exclusion Criteria
Concurrent Medication:
Excluded:
* Phenytoin.
Prior Medication:
Excluded within 30 days of study entry:
* Other antiretroviral agents.
* Patient has any severe ongoing opportunistic infections including Pneumocystis carinii pneumonia (PCP), cryptococcal or to…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000732
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)