Trial Outcomes & Findings for Effect of Raltegravir on Endothelial Function in HIV-Infected Patients (NCT NCT00843713)

NCT ID: NCT00843713

Last Updated: 2018-12-12

Results Overview

Measurements in the change of brachial artery diameter from pre and post treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 56 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2018-12-12

Participant Flow

Participant milestones

Measure	Placebo For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication	Raltegravir For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Overall Study STARTED	30	26
Overall Study COMPLETED	30	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

Baseline characteristics by cohort

Measure	Placebo n=30 Participants For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication	Raltegravir n=26 Participants For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication	Total n=56 Participants Total of all reporting groups
Age, Continuous	53 Years n=5 Participants	54 Years n=7 Participants	53 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants
Race/Ethnicity, Customized African-American	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Race/Ethnicity, Customized Latino	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Measurements in the change of brachial artery diameter from pre and post treatment.

Outcome measures

Measure	Placebo n=30 Participants For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication	Raltegravir n=26 Participants For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)	3.4 millimeters Interval 2.4 to 5.1	2.9 millimeters Interval 2.6 to 5.1

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Raltegravir

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=30 participants at risk For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication	Raltegravir n=26 participants at risk For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Hepatobiliary disorders Hepatocellular Carcinoma	0.00% 0/30	3.8% 1/26
Infections and infestations Infection	3.3% 1/30	0.00% 0/26

Other adverse events

Measure	Placebo n=30 participants at risk For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication	Raltegravir n=26 participants at risk For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/30	3.8% 1/26

Additional Information

Priscilla Hsue, MD

University of California, San Francisco

Phone: 415-206-8257

Email: Priscilla.Hsue@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place