Trial Outcomes & Findings for Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study) (NCT NCT01068873)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

week 48

Results posted on

2020-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Single Arm Drug: lopinavir/ritonavir plus maraviroc lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Single Arm n=1 Participants Drug: lopinavir/ritonavir plus maraviroc lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
Age, Continuous	29 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: week 48

Population: Subject terminated study prior to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 24

Outcome measures

Outcome measures
Measure	Open Label Single Arm n=1 Participants Drug: lopinavir/ritonavir plus maraviroc lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
Number of Participants With HIV RNA < 50 and <400 Copies/ml.	1 Participants

SECONDARY outcome

Timeframe: week 48

Population: Subject terminated study prior to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Population: Subject terminated study prior to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 24, week 48

Population: Analysis was not performed as only one subject was enrolled

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 24, 48

Population: Analysis was not performed because only 1 subject was enrolled and terminated study prior to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 48

Population: Subject terminated study prior to week 48

Outcome measures

Outcome data not reported

Adverse Events

Open Label Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Landsberg

Lewis Katz School of Medicine at Temple University

Phone: 12157077303

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place