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Drugs in Development*

January/February 2002

CompoundClass of CompoundPhase of DevelopmentPharmaceutical Company
ACH-126,443 (L-Fd4C)Nucleoside analogue RT inhibitorPhase IAchilleon
ADAZinc fingerPhase I/IIHubriphar
BMS-232623Protease inhibitorPhase II/IIIBristol-Myers Squibb (BMS)
Calanolide ANon-nucleoside RT inhibitorPhase IISarawak Medichem
CapravirineNon-nucleoside RT inhibitorPhase IIAgouron
DAPDNucleoside analogue RT inhibitorPhase I/IITriangle Pharmaceuticals
DEHSPMInhibits hypusin/eIF-5APhase ISunPharm
DPC 083Non-nucleoside RT inhibitorPhase I(BMS) DuPont Pharmaceuticals
DPC 961Non-nucleoside RT inhibitorPhase I(BMS) DuPont Pharmaceuticals
Emivirine (MKC-442)Non-nucleoside RT inhibitorPhase IIITriangle Pharmaceuticals
Emtricitabine (FTC)Nucleoside analogue RT inhibitorPhase IIITriangle Pharmaceuticals
HydroxyureaInhibits cellular factorsPhase II/IIIBristol-Myers Squibb
MycophenlateInhibits cellular factorsPhase I/IIHoffman-La Roche
PeldesineInhibits cellular factorsPhase IBiocryst
Pentfuside (T-20)Fusion inhibitorPhase IIITrimeris/Roche
PRO 367Entry inhibitorPhase IProgenics
PRO 542Attachment inhibitorPhase I/IIProgenics
ResveratrolInhibits cellular factorsPhase IPharmascience
S1360Integrase inhibitorPhase I/IIShionogi Pharmaceuticals
SCH CCCR5 antagonistPhase ISchering Plough
T-1249Fusion inhibitorPhase ITrimeris/Roche
TipranavirProtease inhibitorPhase I/IIBoehringer Ingelheim
TMC 125Non-nucleoside RT inhibitorPhase IITibotec
TMC 120Non-nucleoside RT inhibitorPhase IITibotec
TMC 126Protease inhibitorPhase ITibotec
VX-175/GW433908 Vertex/GlaxoProtease inhibitorPhase II/IIISmithKline (amprenavir prodrug)
* Source: Ben Cheng, Project Inform. Visit www.atac-usa.org.


Terms

Clinical trials are scientific investigations carried out on human subjects to define the safety, efficacy and effects (toxicity, side effects and interactions) of a drug. The FDA requires strict testing of all new drugs prior to their approval for use as therapeutic agents.

Phase I trials involve the first introduction of an experimental drug to patients or healthy volunteers, normally less than 100 enrollees. They are closely monitored to determine the interaction of the drug, including the side effects associated with different doses. Sufficient information and signs of effectiveness are necessary to permit design of well-controlled Phase II studies.

Phase II trials are well controlled, closely monitored clinical studies, usually with no more than several hundred human subjects. They test the effectiveness of a drug against a particular indication(s) in patients with the disease or condition in question and measure common, short-term side effects and risks associated with the drug.

Phase III trials are expanded controlled and uncontrolled studies, including several hundred to several thousand participants, initiated after preliminary data of drug effectiveness are obtained. These trials seek to gather additional effectiveness and safety information about safety and evaluate the overall benefit-risk relationship of the drug and to provide competent basis for dosing.

Adapted from the HIV/AIDS Treatment Information Service (www.hivatis.org).


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