Trial Outcomes & Findings for Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV (NCT NCT00084149)
NCT ID: NCT00084149
Last Updated: 2021-11-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
At 48 weeks after the start of treatment
Results posted on
2021-11-04
Participant Flow
Participant milestones
| Measure |
Cyclosporine
The Cyclosporine arm (Arm A) will receive one tablet of abacavir sulfate (ABC), lamivudine (3TC), and zidovudine (AZT), (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of lopinavir/ritonavir (LPV/r) twice daily, and liquid cyclosporin A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
The No Cyclosporine arm (Arm B) will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
18
|
|
Overall Study
COMPLETED
|
28
|
13
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV
Baseline characteristics by cohort
| Measure |
A: Cyclosporine
n=28 Participants
Arm A will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
B: Placebo
n=13 Participants
Arm B will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
35 years
n=7 Participants
|
36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
13 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Cluster of differentiation 4 (CD4+) T-cell count
|
407 cells/mm^3
n=5 Participants
|
490 cells/mm^3
n=7 Participants
|
450 cells/mm^3
n=5 Participants
|
|
Plasma log10 HIV viral load
|
5.0 log10(copies/mL)
n=5 Participants
|
4.9 log10(copies/mL)
n=7 Participants
|
5.0 log10(copies/mL)
n=5 Participants
|
PRIMARY outcome
Timeframe: At 48 weeks after the start of treatmentPopulation: All participants completing week 48 visit.
Outcome measures
| Measure |
Cyclosporine
n=28 Participants
Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=13 Participants
No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)
|
1.88 log10(copies/mL)
Interval 1.57 to 2.4
|
1.92 log10(copies/mL)
Interval 1.77 to 2.11
|
SECONDARY outcome
Timeframe: Up to 48 weeksGrade 1-4 adverse events related to study medication
Outcome measures
| Measure |
Cyclosporine
n=28 Participants
Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=13 Participants
No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
Adverse Events Related to Study Medication
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: At Week 24Outcome measures
| Measure |
Cyclosporine
n=28 Participants
Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=13 Participants
No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
Proviral DNA Levels (log10)
|
2.12 log10(copies/mL)
Interval 1.71 to 2.41
|
1.96 log10(copies/mL)
Interval 1.73 to 1.96
|
SECONDARY outcome
Timeframe: At Week 12Outcome measures
| Measure |
Cyclosporine
n=28 Participants
Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=13 Participants
No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
Proviral DNA (log10)
|
2.22 log10(copies/mL)
Interval 1.81 to 2.52
|
2.13 log10(copies/mL)
Interval 1.97 to 2.27
|
SECONDARY outcome
Timeframe: At Week 48Outcome measures
| Measure |
Cyclosporine
n=28 Participants
Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=13 Participants
No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
HIV-1 Viral Load Levels
|
1.70 log10(copies/mL)
Interval 0.0 to 1.7
|
1.70 log10(copies/mL)
Interval 0.0 to 1.7
|
SECONDARY outcome
Timeframe: Week 48Outcome measures
| Measure |
Cyclosporine
n=28 Participants
Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=13 Participants
No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
Number of Patients With Viral Load Less Than 50 Copies/ml
|
27 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: At Week 48Outcome measures
| Measure |
Cyclosporine
n=28 Participants
Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=13 Participants
No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
CD4 T Cell Levels
|
301 cells/mm^3
Interval 146.0 to 432.0
|
287 cells/mm^3
Interval 222.0 to 422.0
|
Adverse Events
Cyclosporine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
No Cyclosporine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyclosporine
n=36 participants at risk
Cyclosporine will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
No Cyclosporine
n=18 participants at risk
No Cyclosporine arm will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks
Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy
Lopinavir/Ritonavir: antiretroviral therapy
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
|
0.00%
0/18 • Up to 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place