Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Efavirenz · 2 trials · 2 indications
Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons: * To resolve a Grade 3 or 4 Adverse Event * The subject experienced a virologic failure (as defined in section 3.6.2) * The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue * The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)
| Arm | Type | Description |
|---|---|---|
| Arm A : Boosted Lexiva plus Epzicom | EXPERIMENTAL | Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg). |
| Arm B: Efavirenz plus Epzicom | EXPERIMENTAL | QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) |
| Name | Type | Description |
|---|---|---|
| Efavirenz 600mg | DRUG | QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) The intervention may be switched for the following reasons: * To resolve a Grade 3 or 4 Adverse Event * The subject experienced a virologic failure (as defined in section 3.6.2) * The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue * The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide) |
| Boosted Lexiva | DRUG | Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) The intervention may be switched for the following reasons: * To resolve a Grade 3 or 4 Adverse Event * The subject experienced a virologic failure (as defined in section 3.6.2) * The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue * The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide) |
| efavirenz | DRUG | - |
| tenofovir | DRUG | - |
| abacavir/lamivudine | DRUG | - |
Inclusion Criteria: Screening plasma HIV-1 RNA viral load \>5000 copies/mL Self-identification as having any non-White/Caucasian European geographic ancestry (i.e., an individual is eligible if she/he does not have any White/Caucasian European ancestry; OR an individual is eligible if she/he indica...
Efavirenz is used for the treatment of Human Immunodeficiency Virus (HIV) infections, including HIV Infection. It is being studied in HIV-infected patients who have not received prior therapy. The drug is in Phase 3 clinical development for this indication.
Efavirenz is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV infections.
Efavirenz is in Phase 3 clinical development. It has completed Phase 3 trials for the treatment of HIV infections, including one study with 345 participants and another with 101 participants. The drug is not yet approved and remains investigational.
Efavirenz has been studied in two completed Phase 3 clinical trials. The first, NCT00053638, enrolled 345 HIV-infected patients who had not received prior therapy. The second, NCT00727597, enrolled 101 patients with Human Immunodeficiency Virus Infections. Both trials were conducted in the United States.
Yes, Efavirenz is a small molecule drug. It is being developed as a therapeutic agent for infectious disease, specifically for the treatment of Human Immunodeficiency Virus infections. The drug is administered to adult patients aged 18 years and older.
Yes, Efavirenz was studied in a controlled clinical trial. The Phase 3 study NCT00053638 was a randomized, controlled trial that enrolled 345 participants. The trial was not double-blind, but it did use a control group to evaluate the drug's effects in HIV-infected patients.