We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Peldesine (BCX-34) in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002237
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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.

Condition Intervention Phase
HIV Infections Drug: Peldesine Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002237


Locations
United States, California
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States, 94109
Sponsors and Collaborators
BioCryst Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00002237     History of Changes
Other Study ID Numbers: 301A
96-009
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: September 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Placebos
Administration, Oral
Anti-HIV Agents
Viral Load
peldesine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases