Trial Outcomes & Findings for Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC (NCT NCT01620944)
NCT ID: NCT01620944
Last Updated: 2024-01-10
Results Overview
Proportion of subjects with HIV-1 RNA \< 40 c/mL at Week 48.
TERMINATED
PHASE3
3 participants
Week 48
2024-01-10
Participant Flow
3 randomized and treated
Participant milestones
| Measure |
Arm A
Reference Therapy: Atazanavir, heat-stable ritonavir \[ATV/RTVHS\] 300/100 mg QD + Tenofovir/emtricitabine \[TDF/FTC\] 300/200 mg QD by mouth for 48 weeks
|
Arm B
Experimental Therapy: Atazanavir, heat-stable ritonavir \[ATV/RTVHS\] 300/100 mg QD + Lamivudine \[3TC\] 300 mg QD by mouth for 48 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm A
Reference Therapy: Atazanavir, heat-stable ritonavir \[ATV/RTVHS\] 300/100 mg QD + Tenofovir/emtricitabine \[TDF/FTC\] 300/200 mg QD by mouth for 48 weeks
|
Arm B
Experimental Therapy: Atazanavir, heat-stable ritonavir \[ATV/RTVHS\] 300/100 mg QD + Lamivudine \[3TC\] 300 mg QD by mouth for 48 weeks
|
|---|---|---|
|
Overall Study
Early termination of Study
|
2
|
1
|
Baseline Characteristics
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
Baseline characteristics by cohort
| Measure |
Arm A
n=2 Participants
Reference Therapy: Atazanavir, heat-stable ritonavir \[ATV/RTVHS\] 300/100 mg QD + Tenofovir/emtricitabine \[TDF/FTC\] 300/200 mg QD by mouth for 48 weeks
|
Arm B
n=1 Participants
Experimental Therapy: Atazanavir, heat-stable ritonavir \[ATV/RTVHS\] 300/100 mg QD + Lamivudine \[3TC\] 300 mg QD by mouth for 48 weeks
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Week 48 not reached for any participant, data not collected at week 48
Proportion of subjects with HIV-1 RNA \< 40 c/mL at Week 48.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: Week 48 not reached for any participant, data not collected at week 48
Proportion of Participants with HIV-1 RNA \< 400 c/mL at Week 48.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96Population: Week 48 not reached for any participant, data not collected at week 96
proportion of subjects with HIV-1 RNA \< 40 c/mL and \< 400 c/mL at Week 96.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through weeks 48 and 96Population: Week 48 and 96 not reached for any participant, data not collected through week 48 and 96
Incidence of Adverse Events through weeks 48 and 96 including serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation. There were no SAEs or AEs reported in this early terminated study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: Week 48 and 96 not reached for any participant, data not collected at week 48 and 96
Percent change from baseline in eGFR and bone mineral density at weeks 48 and 96.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through week 48 and 96Population: Week 48 and 96 not reached for any participant, data not collected through week 48 and 96
Incidence of newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failures through Week 48 and 96.
Outcome measures
Outcome data not reported
Adverse Events
Arm A
Arm B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER