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Zidovudine
Zidovudine (INN) or azidothymidine (AZT) (also called ZDV) is a nucleoside analog reverse transcriptase inhibitor (NRTI), a type of antiretroviral drug. It was the first approved treatment for HIV. It is also sold under the names Retrovir and Retrovis, and as an ingredient in Combivir and Trizivir....
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A Phase I Evaluation of Azidothymidine (AZT) in Children with Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)
The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body. The effects of any drug, the way a drug enters...
Minimum age for eligibility:
- 1
Expected total enrollment:
- 12
Maximum age for eligibility:
- 12
Eligibility exclusion criteria:
- Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth. ,
- Hemoglobinopathy including sickle cell anemia. ,
- Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study. ,
- # Asymptomatic with T-lymphocyte deficiency.
Phase:
Eligibility inclusion criteria:
- * Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements). ,
- Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements).
Diseases:
Location:
View entire collection »References:
- Safety and tolerance of zidovudine in pediatric AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):200 (abstract no FB488) ,
- Enhanced p24 antigen detection in sera from human immunodeficiency virus-infected children ,
- Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group. ,
- The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network.
Health authority:
Type of trial:
ClinicalTrials.gov Identifier:
- NCT00000701
Treatment being tested:
Methadone Effects on Zidovudine (ZDV, AZT) Disposition
To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone...
Minimum age for eligibility:
- 18
Expected total enrollment:
- 15
Eligibility exclusion criteria:
- Inadequate IV access. ,
- Benzodiazepine abuse.
Phase:
Eligibility inclusion criteria:
- Documented HIV infection. ,
- CD4 count 100 - 500 cells/mm3. ,
- No active opportunistic infection or wasting syndrome. ,
- Opiate addiction or prior enrollment in a methadone treatment program (methadone recipients only).
Diseases:
References:
- Methadone effects on zidovudine disposition (AIDS Clinical Trials Group 262) ,
- Methadone increases zidovudine exposure in HIV-infected injection drug users (ACTG 262)
Health authority:
Type of trial:
ClinicalTrials.gov Identifier:
- NCT00000800
Sponsor:
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A Multi-Center Clinical Trial to Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients with AIDS Post First Episode PCP
To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being...
Minimum age for eligibility:
- 12
Expected total enrollment:
- 482
Eligibility exclusion criteria:
- Patients with active opportunistic infections will be excluded. ,
- Other concurrent neoplasms other than basal cell carcinoma of the skin. ,
- Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry. ,
- Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary.
Phase:
Eligibility inclusion criteria:
- HIV seropositivity as confirmed by any federally licensed ELISA test kit.
Diseases:
Location:
- Harvard University ,
- University of California, San Diego ,
- San Francisco AIDS Clinic ,
- Stanford University
Health authority:
Type of trial:
ClinicalTrials.gov Identifier:
- NCT00000700
Treatment being tested:
A Study of Zidovudine in HIV-Infected Patients With Liver Disease
To examine the pharmacokinetics (blood levels) and bioavailability of zidovudine (AZT) given to patients with HIV infection and chronic liver disease. The specific aim of the study is to provide data permitting the development of guidelines for use...
Minimum age for eligibility:
- 18
Health authority:
Type of trial:
ClinicalTrials.gov Identifier:
- NCT00001001
