Trial Outcomes & Findings for Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals (NCT NCT01293123)

NCT ID: NCT01293123

Last Updated: 2019-10-31

Results Overview

Slope of decline of HIV RNA levels in CSF over time

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

180 days

Results posted on

2019-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Raltegravir Raltegravir: raltegravir 400 mg PO twice daily	Efavirenz Efavirenz: efavirenz 600 mg PO once daily
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Raltegravir Raltegravir: raltegravir 400 mg PO twice daily	Efavirenz Efavirenz: efavirenz 600 mg PO once daily
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir n=1 Participants Raltegravir: raltegravir 400 mg PO twice daily	Efavirenz n=1 Participants Efavirenz: efavirenz 600 mg PO once daily	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26 years STANDARD_DEVIATION 0 • n=5 Participants	36 years STANDARD_DEVIATION 0 • n=7 Participants	31 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: Insufficient enrollment for data analysis

Slope of decline of HIV RNA levels in CSF over time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180 days

Population: Insufficient enrollment for data analysis

Change in neuropsychological performance over 180 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180 days

Population: Insufficient enrollment for data analysis

Change in mood over 180 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180 days

Population: Insufficient enrollment for data analysis

Change in self-reported sleep performance over 180 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180 days

Population: Insufficient enrollment for data analysis

Change in self-report quality of life over 180 days

Outcome measures

Outcome data not reported

Adverse Events

Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Efavirenz

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

Scott Letendre, Principal Investigator

University of California, San Diego

Phone: 6195438080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place