1010
Last Update Posted: 2021-11-04
Recruiting has ended
All Genders accepted | 19 Years + |
72 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
To compare the effect of zidovudine (AZT) given alone with the combination of AZT and acyclovir (ACV) on the human immunodeficiency virus (HIV) in persons infected with HIV, and to study the pharmacokinetics (how fast AZT reaches certain levels in blood and how long it remains), safety, and effectiveness of AZT given alone and in combination with ACV in treating HIV-infected patients. Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods, and experiments in vitro (in the test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to obtain information on how these drugs perform in HIV-infected humans.
Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods, and experiments in vitro (in the test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to obtain information on how these drugs perform in HIV-infected humans.
The first 12 patients will take AZT capsules every 4 hours, and 6 of the patients will also take ACV 6 times a day. Later groups of patients will receive higher doses of AZT if the earlier doses are tolerated without significant adverse effect. It was initially planned to stop treatment after 12 weeks, but if the first 10 patients who have entered the study have tolerated treatment well, the duration of treatment will be extended with a crossover in dosage. The treatment may be lifelong, depending on the results obtained with regard to safety and effectiveness of the drugs. Blood and urine samples will be obtained periodically in order to estimate blood levels of the drugs, to study the excretion of the drugs, and to determine the effects of the drugs on HIV and on the immune system and medical condition of the patient.
Eligibility
Relevant conditions:
HIV Infections
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
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Data sourced from ClinicalTrials.gov