A Study of Peldesine (BCX-34) in HIV-Infected Patients
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1999
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.
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients
Patients are given either BCX-35 or placebo for 14 or 28 days. Plasma viral load will be determined at the MTD.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Concomitant therapy with other medications having primary renal excretion (other than 3TC, ddC, and d4T).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002237
|Saint Francis Mem Hosp / HIV Care Unit
|San Francisco, California, United States, 94109 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases