NCT00002047

Completed

Retrovir Capsules in the Treatment of HIV-Infected Patients ...

Glaxo Wellcome Source

Other study identifiers

Sponsor study identifier

014H

Secondary identifiers

27433-19

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief Summary

To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 2, 1999
Actual (reported)
First Posted
August 31, 2001
Actual (reported)

Last Updated: June 24, 2005
Status Verified: May 1990
Last Update Submitted: June 23, 2005

Conditions

HIV Infections Kidney Failure, Chronic

Keywords

Kidney Failure, ChronicAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudineRenal Dialysis

Interventions

ZidovudineDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have:
A positive HIV antibody test (ELISA confirmed by Western blot).

Sponsors & Collaborators

Glaxo Wellcome
Industrylead

Study Sites (1)

Univ of Maryland at Baltimore

Baltimore, Maryland, 21201, United States

MeSH Terms

Conditions

HIV InfectionsKidney Failure, ChronicAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus Diseases

Study Design

Study Type: interventional
Phase: not applicable
Purpose: TREATMENT
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1990-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00002047
Data provider: ClinicalTrials.gov
Source updated: 2005-06-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:02 UTC

Locations

NCT00002048

The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)

Not ApplicableCompleted

NCT00002020

Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC

Not ApplicableCompleted

NCT00002286

A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients

Not ApplicableCompleted

NCT00002063

Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

Not ApplicableCompleted

NCT00002023

An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2

Not ApplicableCompleted

NCT00000662

A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease

Not ApplicableCompleted

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.

You may not qualify if:

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:
+2 more criteria

Contact the study team to confirm eligibility.

Genital Diseases

Urogenital Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Pathologic Processes

Pathological Conditions, Signs and Symptoms

Slow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

US

(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Intervention Hierarchy (Ancestors)