A Study of Lobucavir in Patients With AIDS

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

HIV Infections
Cytomegalovirus Infections

Treatments

Drug: Lobucavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002352
AI459-007
248A

Details and patient eligibility

About

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

Full description

Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Aerosolized pentamidine.
  • TMP / SMX.
  • Isoniazid.
  • Dapsone.
  • Fluconazole.
  • Ketoconazole.
  • Rifabutin.
  • Fluoxetine HCl.
  • Acetaminophen.
  • Antacids.
  • Metamucil.
  • Multivitamins.
  • Other drugs with approval from sponsor.

Patients must have:

  • AIDS.
  • CD4 count < 200 cells/mm3.
  • Cytomegalovirus ( CMV ) viruria and virosemenia.
  • No evidence of intraocular CMV.

Exclusion Criteria

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:

Excluded within 4 weeks prior to study entry:

  • Erythropoietin.
  • Any agent with anti-CMV activity.
  • Other investigational agents.

Prior Treatment:

Excluded within 4 weeks prior to study entry:

  • Surgery.
  • Blood transfusion. Drug abuse.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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