Study: NCT01632345

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doravirine
Description: Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doravirine
Description: Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doravirine
Description: Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doravirine
Description: Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Efavirenz
Description: Efavirenz 600 mg tablet orally at bedtime taken without food on an empty stomach for 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRUVADA®
Description: Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRUVADA®
Description: Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRUVADA®
Description: Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRUVADA®
Description: Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: TRUVADA®
Description: Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for Doravirine
Description: Placebo tablets matching doravirine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for Doravirine
Description: Placebo tablets matching doravirine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for Doravirine
Description: Placebo tablets matching doravirine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for Doravirine
Description: Placebo tablets matching doravirine

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo for Efavirenz
Description: Placebo tablets matching efavirenz