- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002237
A Study of Peldesine (BCX-34) in HIV-Infected Patients
Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients
Study Overview
Detailed Description
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94109
- Saint Francis Mem Hosp / HIV Care Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 301A
- 96-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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