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Drugs in Development*

January/February 2002

Compound Class of Compound Phase of Development Pharmaceutical Company
ACH-126,443 (L-Fd4C) Nucleoside analogue RT inhibitor Phase I Achilleon
ADA Zinc finger Phase I/II Hubriphar
BMS-232623 Protease inhibitor Phase II/III Bristol-Myers Squibb (BMS)
Calanolide A Non-nucleoside RT inhibitor Phase II Sarawak Medichem
Capravirine Non-nucleoside RT inhibitor Phase II Agouron
DAPD Nucleoside analogue RT inhibitor Phase I/II Triangle Pharmaceuticals
DEHSPM Inhibits hypusin/eIF-5A Phase I SunPharm
DPC 083 Non-nucleoside RT inhibitor Phase I (BMS) DuPont Pharmaceuticals
DPC 961 Non-nucleoside RT inhibitor Phase I (BMS) DuPont Pharmaceuticals
Emivirine (MKC-442) Non-nucleoside RT inhibitor Phase III Triangle Pharmaceuticals
Emtricitabine (FTC) Nucleoside analogue RT inhibitor Phase III Triangle Pharmaceuticals
Hydroxyurea Inhibits cellular factors Phase II/III Bristol-Myers Squibb
Mycophenlate Inhibits cellular factors Phase I/II Hoffman-La Roche
Peldesine Inhibits cellular factors Phase I Biocryst
Pentfuside (T-20) Fusion inhibitor Phase III Trimeris/Roche
PRO 367 Entry inhibitor Phase I Progenics
PRO 542 Attachment inhibitor Phase I/II Progenics
Resveratrol Inhibits cellular factors Phase I Pharmascience
S1360 Integrase inhibitor Phase I/II Shionogi Pharmaceuticals
SCH C CCR5 antagonist Phase I Schering Plough
T-1249 Fusion inhibitor Phase I Trimeris/Roche
Tipranavir Protease inhibitor Phase I/II Boehringer Ingelheim
TMC 125 Non-nucleoside RT inhibitor Phase II Tibotec
TMC 120 Non-nucleoside RT inhibitor Phase II Tibotec
TMC 126 Protease inhibitor Phase I Tibotec
VX-175/GW433908 Vertex/Glaxo Protease inhibitor Phase II/III SmithKline (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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