NCT00002352

Brief Summary

The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 2, 2007

Status Verified

October 1, 2007

First QC Date

November 2, 1999

Last Update Submit

October 1, 2007

Conditions

Cytomegalovirus InfectionsHIV Infections

Keywords

Cytomegalovirus InfectionsAcquired Immunodeficiency SyndromeAntiviral Agents

Interventions

LobucavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine.
  • TMP / SMX.
  • Isoniazid.
  • Dapsone.
  • Fluconazole.
  • Ketoconazole.
  • Rifabutin.
  • Fluoxetine HCl.
  • Acetaminophen.
  • Antacids.
  • Metamucil.
  • Multivitamins.
  • Other drugs with approval from sponsor.
  • +5 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness.
  • Inability to take oral medication.
  • Allergy to nucleoside analogs.
  • Diarrheal illness.
  • Poor venous access.
  • Positive test for drugs of abuse.
  • Any other condition that would render patient unsuitable for study.
  • Patients with the following prior conditions are excluded:
  • History of pancreatitis.
  • Recent diarrheal illness.
  • History of weight loss.
  • Acute serious illness within 4 weeks prior to study entry.
  • Prior Medication:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mount Zion Med Ctr / UCSF

San Francisco, California, 94115, United States

Location

San Francisco Veterans Adm Med Cntr

San Francisco, California, 94121, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cytomegalovirus InfectionsHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

lobucavir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus 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

October 2, 2007

Record last verified: 2007-10

Locations

US(3)