Status:
COMPLETED
Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 bloo...
Detailed Description
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 importa...
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 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 toxoplasmosis meningoencephalitis, disseminated herpes simplex or herpes zoster.
- Patient has significant diarrhea at entry ( > 1 watery stool per day).
- Patient has demonstrated prior sensitivity or has experienced significant adverse effects during prior therapy with the drugs to be used in the study.
- Cannot abstain from alcohol or any other drugs during the study.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1990
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00000732
End Date
May 1 1990
Last Update
November 3 2021
Active Locations (1)
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1
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States