CLINICAL TRIALS PROFILE FOR ALOVUDINE

Clinical Trials for Alovudine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00002254 ↗	A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)	Completed	Lederle Laboratories	N/A	To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related complex (ARC) after multiple oral dosing for 16 weeks.
NCT00002260 ↗	An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects	Completed	Lederle Laboratories	N/A	To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT
NCT00002271 ↗	An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects	Completed	Lederle Laboratories	N/A	To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and to assess the safety and tolerance of the single oral doses of FLT.
NCT01251874 ↗	Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 1	This phase I trial studies the side effects and best dose of veliparib when given together with carboplatin and to see how well they work in treating patients with human epidermal growth factor 2 (HER2)-negative breast cancer that has spread to other parts of the body. Carboplatin kills cancer cells by damaging the deoxyribonucleic acid (DNA) that lets the cancer cell survive and reproduce. The body has proteins that try to repair the damaged DNA. Veliparib may prevent these proteins from repairing the DNA so that carboplatin may be able to kill more tumor cells. Giving veliparib with carboplatin may kill more tumor cells than carboplatin alone.
NCT02232581 ↗	Study to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure	Completed	Boehringer Ingelheim	Phase 2	The primary objective was to determine the mean change in HIV viral load from baseline to Week 4 compared with placebo after 4 weeks of treatment in highly experienced HIV-infected patients. Secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety of different doses of alovudine and (2) the effect of baseline nucleoside genotypic susceptibility on virologic response after 4 weeks of alovudine administration
NCT02392429 ↗	FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring response in patients with previously untreated acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in the body. FLT is injected into the blood and builds up in cells that are dividing, including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to earlier treatment.

Clinical Trial Conditions for Alovudine

Condition Name

Condition Name for
Intervention	Trials
HIV Infections	4
Acute Myeloid Leukemia	2
BRCA2 Mutation Carrier	1
Progesterone Receptor Positive	1

Condition MeSH

Condition MeSH for
Intervention	Trials
HIV Infections	4
Immunologic Deficiency Syndromes	3
Acquired Immunodeficiency Syndrome	3
Leukemia, Myeloid, Acute	2

Clinical Trial Locations for Alovudine

Trials by Country

Trials by Country for
Location	Trials
United States	19

Trials by US State

Trials by US State for
Location	Trials
New York	3
Maryland	3
North Carolina	2
California	1
Wisconsin	1

Clinical Trial Progress for Alovudine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	1
N/A	3

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	5
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for Alovudine

Sponsor Name

Sponsor Name for
Sponsor	Trials
National Cancer Institute (NCI)	4
Lederle Laboratories	3
Boehringer Ingelheim	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
NIH	4
Industry	4
Other	2