Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abacavir/Lamivudine · 1 trial · 1 indication
Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or \>=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
| Arm | Type | Description |
|---|---|---|
| EFV, FTC/TDF, and placebo ABC/3TC | EXPERIMENTAL | Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
| EFV, ABC/3TC and placebo FTC/TDF | EXPERIMENTAL | Participants will receive EFV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks |
| RTV-boosted ATV, FTC/TDF, and placebo ABC/3TC | EXPERIMENTAL | Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
| RTV-boosted ATV, ABC/3TC, and placebo FTC/TDF | EXPERIMENTAL | Participants will receive RTV-boosted ATV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks |
| Name | Type | Description |
|---|---|---|
| Abacavir/Lamivudine | DRUG | 600 mg abacavir/300 mg lamivudine tablet taken orally daily |
| Atazanavir | DRUG | 300 mg tablet taken orally daily |
| Efavirenz | DRUG | 600 mg tablet taken orally daily |
| Emtricitabine/Tenofovir disoproxil fumarate | DRUG | 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily |
| Ritonavir | DRUG | 100 mg tablet taken orally daily |
| Abacavir/Lamivudine placebo | DRUG | Placebo tablet taken orally daily |
| Emtricitabine/Tenofovir disoproxil fumarate placebo | DRUG | Placebo tablet taken orally daily |
Inclusion Criteria: * HIV-infected. A resistance assay must be obtained if the participant has evidence of recent infection. More information on this criterion can be found in the protocol. * Antiretroviral naive, defined as 7 days or less of ARV treatment at any time prior to study entry. Particip...
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Abacavir/Lamivudine is a fixed-dose combination of two antiretroviral drugs used for the treatment of HIV infections. It is being developed as a small molecule therapy for HIV. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for commercial use.
Abacavir/Lamivudine is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this combination therapy for the treatment of HIV infections.
Abacavir/Lamivudine is in Phase 3 clinical development. It is an investigational drug for the treatment of HIV infections and is not yet approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform potential regulatory submissions.
Abacavir/Lamivudine has been studied in one completed Phase 3 clinical trial, identified as NCT00118898. This trial enrolled 1,864 participants with HIV infections across the United States and Puerto Rico. The study compared efavirenz or atazanavir/ritonavir given with emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine in treatment-naive adults.
Abacavir/Lamivudine is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of HIV infections. The completed Phase 3 trial will provide data to support potential regulatory approval, but the drug has not yet received marketing authorization.