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A Study of Peldesine (BCX-34) in HIV-Infected Patients
This study has been completed.
Study NCT00002237   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002237 on ClinicalTrials.gov Archive Site
 
 
 
A Study of Peldesine (BCX-34) in HIV-Infected Patients
Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients

The purpose of this study is to determine the highest amount of peldesine that is safe. This study will also see if this amount of peldesine is effective in lowering HIV levels in the blood.

Patients are given either BCX-35 or placebo for 14 or 28 days. Plasma viral load will be determined at the MTD.

Phase I
Interventional
Treatment, Placebo Control, Safety Study
HIV Infections
Drug: Peldesine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4 cell count greater than or equal to 300 cells/mm3 on 3 occasions prior to protocol treatment.
  • Plasma viral load by Roche Amplicor HIV Monitor assay greater than or equal to 2,000 RNA copies/ml and less than or equal to 50,000 RNA copies/ml on at least 2 occasions prior to protocol treatment.
  • Normal or non-diagnostic electrocardiogram.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Severe opportunistic infection or any other medical condition which in the opinion of the investigators is a contraindication to enrolling in this trial.
  • Severe lactose intolerance.

Concurrent Medication:

Excluded:

Concomitant therapy with other medications having primary renal excretion (other than 3TC, ddC, and d4T).

Prior Medication:

Excluded:

  • Ongoing dideoxyinosine or other antiretroviral therapy except ZDV, 3TC, ddC, d4T, saquinavir, ritonavir, indinavir, and nelfinavir within 2 weeks of study.
  • Participation in a study of any systemic experimental drug within the last 2 months.

Required:

- Ongoing (at least 4 weeks) stable dosage of zidovudine (ZDV) and lamivudine (3TC), ZDV and stavudine (d4T), ZDV and zalcitabine (ddC), d4T and 3TC, ZDV alone, or ddC alone, or in combination with saquinavir, ritonavir, indinavir, or nelfinavir.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002237
 
301A, 96-009
BioCryst Pharmaceuticals
 
 
NIH AIDS Clinical Trials Information Service
September 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP