CLINICAL TRIALS PROFILE FOR TRUVADA

505(b)(2) Clinical Trials for Truvada

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	NCT00641641 ↗	The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection	Completed	Merck Sharp & Dohme Corp.	N/A	2008-03-01	The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Combination	NCT00641641 ↗	The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection	Completed	Kirby Institute	N/A	2008-03-01	The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.

All Clinical Trials for Truvada

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	HIV Prevention Trials Network	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	Adult AIDS Clinical Trials Group	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	AIDS Clinical Trials Group	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
NCT00105079 ↗	GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection	Completed	Hoffmann-La Roche	Phase 3	2005-04-01	This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Clinical Trial Conditions for Truvada

Condition Name

Condition Name for Truvada
Intervention	Trials
HIV Infections	80
Hiv	55
HIV Infection	21
HIV-1 Infection	10

Condition MeSH

Condition MeSH for Truvada
Intervention	Trials
HIV Infections	128
Acquired Immunodeficiency Syndrome	47
Infections	36
Infection	28

Clinical Trial Locations for Truvada

Trials by Country

Trials by Country for Truvada
Location	Trials
United States	535
Canada	61
South Africa	58
United Kingdom	40
France	37

Trials by US State

Trials by US State for Truvada
Location	Trials
California	52
Florida	34
North Carolina	33
Texas	33
Massachusetts	31

Clinical Trial Progress for Truvada

Clinical Trial Phase

Clinical Trial Phase for Truvada
Clinical Trial Phase	Trials
Phase 4	78
Phase 3	51
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for Truvada
Clinical Trial Phase	Trials
Completed	162
Unknown status	15
Recruiting	13

Clinical Trial Sponsors for Truvada

Sponsor Name

Sponsor Name for Truvada
Sponsor	Trials
Gilead Sciences	59
Merck Sharp & Dohme Corp.	36
National Institute of Allergy and Infectious Diseases (NIAID)	29

Sponsor Type

Sponsor Type for Truvada
Sponsor	Trials
Other	350
Industry	152
NIH	50