Status:
COMPLETED
Evaluation of the Interaction Between High 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 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 blo...
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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1990
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00000734
End Date
May 1 1990
Last Update
October 28 2021
Active Locations (1)
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1
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States