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Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV

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ClinicalTrials.gov Identifier: NCT00084149
Recruitment Status : Completed
First Posted : June 8, 2004
Results First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Abacavir sulfate, Lamivudine, and Zidovudine
Drug: Lopinavir/Ritonavir
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 36 18
Completed 28 13
Not Completed 8 5
Arm/Group Title A: Cyclosporine B: Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 28 13 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 28 participants 13 participants 41 participants
36
(30 to 40)
35
(30 to 43)
36
(30 to 42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 13 participants 41 participants
Female
1
   3.6%
0
   0.0%
1
   2.4%
Male
27
  96.4%
13
 100.0%
40
  97.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 13 participants 41 participants
White 20 10 30
Hispanic 8 1 9
African American 0 1 1
Other 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 13 participants 41 participants
28 13 41
Cluster of differentiation 4 (CD4+) T-cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 28 participants 13 participants 41 participants
407
(340 to 587)
490
(399 to 623)
450
(365 to 605)
Plasma log10 HIV viral load  
Median (Inter-Quartile Range)
Unit of measure:  log10(copies/mL)
Number Analyzed 28 participants 13 participants 41 participants
5.0
(4.9 to 5.8)
4.9
(4.5 to 5.8)
5.0
(4.7 to 5.8)
1.Primary Outcome
Title Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)
Hide Description [Not Specified]
Time Frame At 48 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants completing week 48 visit.
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 28 13
Median (Inter-Quartile Range)
Unit of Measure: log10(copies/mL)
1.88
(1.57 to 2.40)
1.92
(1.77 to 2.11)
2.Secondary Outcome
Title Adverse Events Related to Study Medication
Hide Description Grade 1-4 adverse events related to study medication
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description:

Cyclosporine arm (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

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 Number of Participants Analyzed 28 13
Measure Type: Number
Unit of Measure: participants
1 0
3.Secondary Outcome
Title Proviral DNA Levels (log10)
Hide Description [Not Specified]
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description:

Cyclosporine arm (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

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 Number of Participants Analyzed 28 13
Median (Inter-Quartile Range)
Unit of Measure: log10(copies/mL)
2.12
(1.71 to 2.41)
1.96
(1.73 to 1.96)
4.Secondary Outcome
Title Proviral DNA (log10)
Hide Description [Not Specified]
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description:

Cyclosporine arm 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 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 Number of Participants Analyzed 28 13
Median (Inter-Quartile Range)
Unit of Measure: log10(copies/mL)
2.22
(1.81 to 2.52)
2.13
(1.97 to 2.27)
5.Secondary Outcome
Title HIV-1 Viral Load Levels
Hide Description [Not Specified]
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description:

Cyclosporine arm 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 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

Overall Number of Participants Analyzed 28 13
Mean (95% Confidence Interval)
Unit of Measure: log10(copies/mL)
1.70
(0 to 1.70)
1.70
(0 to 1.70)
6.Secondary Outcome
Title Number of Patients With Viral Load Less Than 50 Copies/ml
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description:

Cyclosporine arm 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 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

Overall Number of Participants Analyzed 28 13
Measure Type: Count of Participants
Unit of Measure: Participants
27
  96.4%
13
 100.0%
7.Secondary Outcome
Title CD4 T Cell Levels
Hide Description [Not Specified]
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description:

Cyclosporine arm 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 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

Overall Number of Participants Analyzed 28 13
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
301
(146 to 432)
287
(222 to 422)
Time Frame Up to 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cyclosporine No Cyclosporine
Hide Arm/Group Description

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 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

All-Cause Mortality
Cyclosporine No Cyclosporine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Cyclosporine No Cyclosporine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cyclosporine No Cyclosporine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/36 (2.78%)      0/18 (0.00%)    
Gastrointestinal disorders     
Vomiting *  1/36 (2.78%)  1 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Florin Vaida
Organization: University of California, San Diego
Phone: 619 543-8045
EMail: fvaida@ucsd.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00084149    
Other Study ID Numbers: AIN501/A5216
10023 ( Registry Identifier: DAIDS ES )
First Submitted: June 7, 2004
First Posted: June 8, 2004
Results First Submitted: January 5, 2016
Results First Posted: September 13, 2018
Last Update Posted: September 13, 2018