Trial Outcomes & Findings for Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection (NCT NCT02384395)
NCT ID: NCT02384395
Last Updated: 2021-11-22
Results Overview
Total number of participants on study at Week 24 with an HIV-1 RNA level less than 200 copies/mL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Week 24
Results posted on
2021-11-22
Participant Flow
Participant milestones
| Measure |
DTG/3TC/ABC FDC
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
Enrolled
|
40
|
|
Overall Study
Initiated Treatment
|
37
|
|
Overall Study
Completed Week 24
|
34
|
|
Overall Study
Completed Week 48
|
33
|
|
Overall Study
Completed Week 96
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
DTG/3TC/ABC FDC
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
Baseline characteristics by cohort
| Measure |
DTG/3TC/ABC FDC
n=37 Participants
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
|
|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
|
Baseline CD4 Count
|
478 cells/mm^3
n=5 Participants
|
|
Baseline HIV-1 RNA PCR Level
|
382000 copies/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Excludes 3 participants who terminated prior to Week 24
Total number of participants on study at Week 24 with an HIV-1 RNA level less than 200 copies/mL
Outcome measures
| Measure |
DTG/3TC/ABC FDC
n=34 Participants
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
|
|---|---|
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Number of Participants With Viral Load Measurement <200 Copies/mL at Week 24
|
34 Participants
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SECONDARY outcome
Timeframe: Baseline through Week 96Population: Two participants had data collected outside of Week 96 window
Sign/symptom, lab toxicity, or clinical events, or Grade 3 or higher AE that is definitely, probably, or possibly related to study treatment
Outcome measures
| Measure |
DTG/3TC/ABC FDC
n=37 Participants
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
|
|---|---|
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Number of Participants With Grade 3 or Higher Adverse Event (AE)
|
1 Participants
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SECONDARY outcome
Timeframe: Week 48Proportion of participants completing Week 48 with an HIV-1 RNA level less than 50 copies/mL
Outcome measures
| Measure |
DTG/3TC/ABC FDC
n=33 Participants
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
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|---|---|
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Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48
|
0.88 proportion of participants
Interval 0.72 to 0.97
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Excludes 3 participants who terminated prior to Week 24
Outcome measures
| Measure |
DTG/3TC/ABC FDC
n=34 Participants
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
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|---|---|
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Median Change HIV-1 RNA Level Among Participants Completing Week 24 Visit
|
-590211 copies/mL
Interval -9999980.0 to -1830.0
|
Adverse Events
DTG/3TC/ABC FDC
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTG/3TC/ABC FDC
n=37 participants at risk
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
|
|---|---|
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Respiratory, thoracic and mediastinal disorders
Exacerbation of Asthma
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Infections and infestations
Acute Bronchitis
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Psychiatric disorders
Acute Stress Reaction
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
General disorders
Chest Pain associated with Back Pain
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Eye disorders
Anterior Uveitis
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Infections and infestations
Left Scrotal Cellulitis
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Infections and infestations
Left Scrotal Abscess
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis without coma associated with T1DM
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Investigations
Elevated Alanine Aminotransferase (ALT)
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Investigations
Elevated Aspartate Aminotransferase (AST)
|
2.7%
1/37 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
Other adverse events
| Measure |
DTG/3TC/ABC FDC
n=37 participants at risk
Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
|
|---|---|
|
Investigations
ALT Increased
|
8.1%
3/37 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Injury, poisoning and procedural complications
Citrate Sensitivity
|
5.4%
2/37 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Investigations
Creatinine Clearance Decreased
|
18.9%
7/37 • Number of events 8 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Gastrointestinal disorders
Nausea
|
18.9%
7/37 • Number of events 8 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Injury, poisoning and procedural complications
Elevated BP During Leukapheresis
|
35.1%
13/37 • Number of events 16 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
General disorders
IV Infiltration During Leukapheresis
|
10.8%
4/37 • Number of events 5 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
2/37 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 96 weeks.
|
Additional Information
Cynthia Gay, MD, MPH
University of North Carolina at Chapel Hill
Phone: 919-966-6712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place