The primary objectives of this study are to evaluate the antiretroviral activity and to evaluate the safety and tolerability of open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg in treatment-naive HIV-1 infected participants with selected NNRTI transmitted resistance mutations.
Name: MK-1439A
Description: A single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.Type: DrugDOR/3TC/TDF
Description: The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit.
Measure: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48 Time: Week 48Description: The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measure: Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48 Time: Up to Week 48Description: The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measure: Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48. Time: Up to Week 48Description: The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measure: Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96 Time: Up to Week 96Description: The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measure: Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96 Time: Up to Week 96Description: The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit.
Measure: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96 Time: Week 96Description: The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
Measure: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48 Time: Week 48Description: The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
Measure: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96 Time: Week 96Description: The change from baseline in CD4 cell count at Week 48 was calculated.
Measure: Change From Baseline in CD4 Cell Count at Week 48 Time: Baseline (Day 1) and Week 48Description: The change from baseline in CD4 cell count at Week 96 was calculated.
Measure: Change From Baseline in CD4 Cell Count at Week 96 Time: Baseline (Day 1) and Week 96Description: The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement.
Measure: Time to Loss of Virologic Response Time: Up to Week 96Single Group Assignment
There are 3 SNPs
- Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A. --- K103N --- --- Y181C --- --- G190A ---
- Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A. --- K103N ---
- Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A. --- K103N --- --- Y181C ---