Cefaclor capsules |
Ceclor |
Clinical Trial: Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
This study has been completed.
|
Purpose
To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.
| Condition | Treatment or Intervention |
|---|---|
| HIV Infections Kidney Failure, Chronic | Drug: Zidovudine |
MedlinePlus related topics: AIDS; Kidney Failure
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Patients must have:
- A positive HIV antibody test (ELISA confirmed by Western blot).
- Chronic renal failure managed by a stable hemodialysis regimen.
- Acceptable hepatic function defined by specified lab values.
- Life expectancy > 6 months.
- Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry.
Exclusion Criteria
Co-existing Condition: Patients with the following are excluded:
- Active, serious opportunistic infections at the time of study entry.
- Fever > 100 degrees F at study entry.
- Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss).
Patients with the following are excluded:
- Active, serious opportunistic infections at the time of study entry.
- Fever > 100 degrees F at study entry.
- Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss).
Prior Medication: Excluded within 2 weeks of study entry:
Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity. Excluded within 4 weeks of study entry:
Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2. Excluded within 8 weeks of study entry:
Other antiretroviral agents (e.g., zidovudine [AZT], suramin, ribavirin, HPA-23, foscarnet, dextran sulfate, disulfiram, ddA/ddC, or dideoxycytidine). Active drug or alcohol abuse.
Location Information
Maryland
Univ of Maryland at Baltimore, Baltimore, Maryland, 21201, United States
More Information
Record last reviewed: May 1990
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002047
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Not Signed In -

