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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peldesine
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Placebos, Administration, Oral, Anti-HIV Agents, Viral Load, peldesine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Francis Mem Hosp / HIV Care Unit

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002237
Brief Title
A Study of Peldesine (BCX-34) in HIV-Infected Patients
Official Title
Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Placebos, Administration, Oral, Anti-HIV Agents, Viral Load, peldesine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Peldesine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Saint Francis Mem Hosp / HIV Care Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33448731
Citation
Mboup A, Diabate S, Behanzin L, Guedou FA, Zannou DM, Keke RK, Bachabi M, Gangbo F, Marzinke MA, Hendrix C, Gagnon MP, Alary M. Determinants of HIV Preexposure Prophylaxis Adherence Among Female Sex Workers in a Demonstration Study in Cotonou, Benin: A Study of Behavioral and Demographic Factors. Sex Transm Dis. 2021 Aug 1;48(8):565-571. doi: 10.1097/OLQ.0000000000001373.
Results Reference
derived
PubMed Identifier
31291057
Citation
Mboup A, Behanzin L, Guedou FA, Geraldo N, Goma-Matsetse E, Giguere K, Aza-Gnandji M, Kessou L, Diallo M, Keke RK, Bachabi M, Dramane K, Geidelberg L, Cianci F, Lafrance C, Affolabi D, Diabate S, Gagnon MP, Zannou DM, Gangbo F, Boily MC, Vickerman P, Alary M. Early antiretroviral therapy and daily pre-exposure prophylaxis for HIV prevention among female sex workers in Cotonou, Benin: a prospective observational demonstration study. J Int AIDS Soc. 2018 Nov;21(11):e25208. doi: 10.1002/jia2.25208.
Results Reference
derived

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

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