Trial Outcomes & Findings for Pilot Study of Effect of Kaletra on CD4 Response in HIV Positive (+) Patients With Viral Suppression KIMBO Study (NCT NCT00344487)
NCT ID: NCT00344487
Last Updated: 2022-01-24
Results Overview
TERMINATED
NA
3 participants
6 and 12 months
2022-01-24
Participant Flow
This study received IRb approval on 12/7/05. Recruitment was difficult and the inclusion criteria was amended in November 2007 to help increase enrollment.
Participant milestones
| Measure |
Kaletra
Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Kaletra
Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
|
|---|---|
|
Overall Study
immunologic failure
|
1
|
Baseline Characteristics
Pilot Study of Effect of Kaletra on CD4 Response in HIV Positive (+) Patients With Viral Suppression KIMBO Study
Baseline characteristics by cohort
| Measure |
Kaletra
n=3 Participants
Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 monthsPopulation: 3 patients enrolled but study terminated early due to lack of enrollment at other sites, thus unable to carry out full data analysis.Unable to report any data because original PI retired and have no access to records.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 6 and 12 monthsPopulation: 3 patients enrolled but study terminated early due to lack of enrollment at other sites, thus unable to carry out full data analysis.Unable to report any data because original PI retired and have no access to records.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 and 12 monthsPopulation: 3 patients enrolled but study terminated early due to lack of enrollment at other sites, thus unable to carry out full data analysis.Unable to report any data because original PI retired and have no access to records.
Baseline Will be Defined as the Mean of 2 Values Obtained Prior to the Medication Switch (for Analysis Purposes, the CD4 Cell Counts at 6 and 12 Months Will be Defined by the Mean of the CD4 Cell Counts Obtained at Months 3, 6 or 9, 12, Respectively).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 and 12 monthsPopulation: 3 patients enrolled but study terminated early due to lack of enrollment at other sites, thus unable to carry out full data analysis.Unable to report any data because original PI retired and have no access to records.
Changes in Slope of CD4 as Assessed 6 Months Prior to the Lopinavir/Ritonavir Switch (baseline). Compared to 6-12 Month Intervals Post Initiation of Lopinavir/Ritonavir (Slope 1-6 Months, 1-12 Months)
Outcome measures
Outcome data not reported
Adverse Events
Kaletra
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Charles E. Davis, Jr. MD
University of Maryland Institute of Human Virology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place