Pharmacokinetic interaction between zidovudine and valproic acid in patients infected with human immunodeficiency virus.
J J Lertora, A B Rege, D L Greenspan...
https://pubmed.ncbi.nlm.nih.gov/7924122Completed
Phase 1
Age: 18Years - 50Years
MALE
ID00000629
The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2008-07-30
6
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary objective: To study the pharmacokinetic interaction between zidovudine (AZT) and valproic acid in asymptomatic HIV-infected patients, characterizing AZT's oral bioavailability, plasma elimination half-time, plasma levels, and urinary excretion of AZT, 5'-O-glucuronide (GAZT), and 3'-amino-3'-deoxythymidine (AMT). Secondary objective: To establish the safety of short-term administration of AZT and valproic acid in combination with regard to hematologic parameters and liver function in asymptomatic HIV-infected patients. Preliminary studies using human liver tissue have shown that valproic acid inhibits the metabolic inactivation of zidovudine (AZT), which may prolong the plasma half-life of AZT and thus prolong the duration of the drug's effects in the body.
CONDITIONS
Official Title
The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
Who Can Participate
Age: 18Years - 50Years
MALE
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
Vitamins if already being taken prior to start of therapy.
Patients must have:
- Asymptomatic HIV infection.
- CD4 count between 300 and 650.
Prior Medication:
Required:
- AZT at doses between 500 and 1200 mg/day for at least 6 weeks prior to enrollment.
Allowed:
- Aspirin, Tylenol, or ibuprofen up to 48 hours prior to start of therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Positive Hepatitis B surface antigen or clinical evidence of chronic active hepatitis of any type.
- Signs or symptoms of HIV infection including oral candidiasis, history of multidermatomal zoster, unexplained weight loss in excess of 10 percent body weight in the past 6 months, chronic diarrhea, or history of AIDS-defining opportunistic infections.
Concurrent Medication:
Excluded:
- Concomitant medications (other than AZT) for the 14 days prior to start of therapy.
Patients with the following prior conditions are excluded:
- History of AZT intolerance including hematologic, hepatic, and/or neurologic toxicity.
- History of seizures.
- History of any antiepileptics within the past 10 years.
- History of abnormal bleeding or intrinsic or extrinsic coagulopathy.
- Signs or symptoms of HIV infection including oral candidiasis, history of multidermatomal zoster, unexplained weight loss in excess of 10 percent body weight in the past 6 months, chronic diarrhea, or history of AIDS-defining opportunistic infections.
Prior Medication:
Excluded:
- Antiepileptics within the past 10 years.
- Prior valproic acid.
- Concomitant medications (other than AZT) within 14 days of enrollment.
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
Tulane Univ Med School
New Orleans, Louisiana, United States, 701122699
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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