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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR EFAVIRENZ


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505(b)(2) Clinical Trials for Efavirenz

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Efavirenz

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000885 ↗ Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320 Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.] Group B: To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms. Group C: To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV. Group D: To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV. This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.]
NCT00000893 ↗ Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 1997-10-01 Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels of EFZ and NFV in the blood. (This purpose reflects a change from the original since there are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily can be combined with other drugs to treat HIV. This is an early study to determine a safe and effective dose for HIV-positive children. This study also will examine the correct dose of NFV to use in combination with EFZ.
NCT00000893 ↗ Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1997-10-01 Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels of EFZ and NFV in the blood. (This purpose reflects a change from the original since there are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily can be combined with other drugs to treat HIV. This is an early study to determine a safe and effective dose for HIV-positive children. This study also will examine the correct dose of NFV to use in combination with EFZ.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Efavirenz

Condition Name

Condition Name for Efavirenz
Intervention Trials
HIV Infections 205
Hiv 53
HIV Infection 39
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Condition MeSH

Condition MeSH for Efavirenz
Intervention Trials
HIV Infections 281
Acquired Immunodeficiency Syndrome 66
Infections 51
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Clinical Trial Locations for Efavirenz

Trials by Country

Trials by Country for Efavirenz
Location Trials
South Africa 86
Spain 82
Canada 78
Thailand 52
United Kingdom 49
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Trials by US State

Trials by US State for Efavirenz
Location Trials
California 98
New York 82
Texas 68
Illinois 67
Florida 63
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Clinical Trial Progress for Efavirenz

Clinical Trial Phase

Clinical Trial Phase for Efavirenz
Clinical Trial Phase Trials
Phase 4 104
Phase 3 93
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Efavirenz
Clinical Trial Phase Trials
Completed 317
Unknown status 36
Terminated 19
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Clinical Trial Sponsors for Efavirenz

Sponsor Name

Sponsor Name for Efavirenz
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 75
Gilead Sciences 44
Bristol-Myers Squibb 28
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Sponsor Type

Sponsor Type for Efavirenz
Sponsor Trials
Other 466
Industry 242
NIH 114
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