Trial Outcomes & Findings for Kaletra and Viread in Antiretroviral Naïve Patients (NCT NCT00679926)
NCT ID: NCT00679926
Last Updated: 2020-12-04
Results Overview
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to \<50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
TERMINATED
PHASE4
6 participants
4, 8, 12, 16, 24, 32, 40, and 48 weeks
2020-12-04
Participant Flow
Recruitment was July 2009 to January 2011 and was completed at the Internal Medicine Specialty Clinic at OSU-CHS.
There are no significant events prior to enrollment. Patients had to be naive to HIV therapy prior to treatment drug.
Participant milestones
| Measure |
Single Treatment Arm
Patients taking lopinavir/ritonavir and tenofovir once daily.
Lopinavir/ritonavir and tenofovir : Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Kaletra and Viread in Antiretroviral Naïve Patients
Baseline characteristics by cohort
| Measure |
Single Treatment Arm
n=15 Participants
Patients taking lopinavir/ritonavir and tenofovir once daily.
Lopinavir/ritonavir and tenofovir : Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4, 8, 12, 16, 24, 32, 40, and 48 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to \<50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4,8, and 12 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Proportion of patients with \<400copies/ml will be done by determining plasma HIV-1 RNA levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, and 24Population: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Review virologic response to assess rate of viral decline through CD4 count at baseline and throughout the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at weeks 4, 8, 12, 16, 24, 32, 40, and 48Population: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Proportion of patients with \<50 copies/ml HIV-1 RNA through evaluation of patients Plasma HIV-1 RNA levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at weeks 4, 8, 12, 16, 24, 32, 40, and 48Population: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
CD4 count done at baseline and throughout the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Virologic failure is defined by any of the following: 1) \<1 log10 decline in HIV RNA by week 8 of therapy; 2) failure to achieve \<50 c/mL by week 24; 3) HIV RNA\> 500 c/ML on two consecutive occasions (less than 30 days apart), with no evidence of suppression after adherence counseling. When HIV RNA levels are obtained \>500 copies/mL it will be repeated within 2 weeks. If after adherence counseling, HIV RNA demonstrates \> 1 log 10 decline but remains \>500, the patient will receive a final adherence counseling session and have his/her HIV RNA measure repeated at day 30: if a third consecutive HIV RNA remains 500 c/mL the patient will be removed from study, if \<500c/mL the patient will remain on study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Adverse events and safety parameters are monitored for ll subjects for the duration of the study. Toxicities and adverse events will be graded using the modified ACTG toxicity ratings scale. Study drugs may be interrupted for safety reasons and/or based on grade of toxicity/adverse event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Change from baseline fasting total cholesterol and fasting triglyceride levels will be measured by fasting lipid panels taken at baseline and at various timepoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
The medication event monitoring system (MEMS) is a cap that fits on standard medicine bottles and records the time and date each time the bottle is opened and closed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records is assessed by an examination of pharmacy refill data for patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
At time of virologic failure genotypes will be performed on baseline and failure isolates; phenotypic testing will be performed on failure isolates to examine LPV susceptibility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated due to lack of enrollment and data were not collected from 13 out of 15 participants.
Assess lopinavir trough levels in patients failing to obtain virologic suppression by measuring lopinavir trough level
Outcome measures
Outcome data not reported
Adverse Events
Single Treatment Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Johnny Stephens
Oklahoma State University Center for Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place