CLINICAL TRIALS PROFILE FOR EPIVIR

505(b)(2) Clinical Trials for EPIVIR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Gilead Sciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

All Clinical Trials for EPIVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002168 ↗	A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients	Completed	Bristol-Myers Squibb	N/A	1969-12-31	The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
NCT00002183 ↗	A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection	Completed	Glaxo Wellcome	Phase 1	1969-12-31	To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV infection as measured by the development of clinical adverse experiences and laboratory test abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to Retrovir/Epivir or to 1592U89/Retrovir/Epivir.
NCT00002195 ↗	A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 3	1969-12-31	The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
NCT00002203 ↗	A Study of Two Anti-HIV Drug Combinations	Completed	Glaxo Wellcome	N/A	1969-12-31	The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs. Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
NCT00002215 ↗	A Randomized, Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir + Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive	Completed	Triangle Pharmaceuticals	N/A	1969-12-31	To compare the proportion of patients whose plasma HIV-1 RNA level falls and remains below the limit of quantification by the Roche Amplicor Monitor (400 copies/ml)[AS PER AMENDMENT 8/4/98: 50 copies/ml] between weeks 0 and 24. To determine the short-term safety and tolerability of MKC-442 plus nelfinavir (Viracept) plus dual nucleoside analogs. To determine the time to viral failure and time to tolerability failure through Week 48 of therapy.

Clinical Trial Conditions for EPIVIR

Condition Name

Condition Name for EPIVIR
Intervention	Trials
HIV Infections	26
HIV	4
HIV-1 Infection	4
HIV Infection	2

Condition MeSH

Condition MeSH for EPIVIR
Intervention	Trials
HIV Infections	31
Acquired Immunodeficiency Syndrome	8
Infections	7
Infection	7

Clinical Trial Locations for EPIVIR

Trials by Country

Trials by Country for EPIVIR
Location	Trials
United States	118
Korea, Republic of	7
Spain	7
India	7
Germany	6

Trials by US State

Trials by US State for EPIVIR
Location	Trials
New York	12
California	11
Texas	8
Illinois	7
District of Columbia	6

Clinical Trial Progress for EPIVIR

Clinical Trial Phase

Clinical Trial Phase for EPIVIR
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for EPIVIR
Clinical Trial Phase	Trials
Completed	36
Unknown status	4
Recruiting	2

Clinical Trial Sponsors for EPIVIR

Sponsor Name

Sponsor Name for EPIVIR
Sponsor	Trials
Glaxo Wellcome	8
National Institute of Allergy and Infectious Diseases (NIAID)	8
Bristol-Myers Squibb	5

Sponsor Type

Sponsor Type for EPIVIR
Sponsor	Trials
Other	37
Industry	27
NIH	17