Trial Outcomes & Findings for R5 Integrase Study in HIV-1 Naive Patients (NCT NCT01204905)

Last Updated: 2022-11-14

Results Overview

Percentage of subjects with HIV-1 viral load \< 50 copies/ml

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

48 weeks

Results posted on

2022-11-14

Participant milestones
Measure	Open Label ART Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Withdrawal data not reported

R5 Integrase Study in HIV-1 Naive Patients

Baseline characteristics by cohort
Measure	Open Label ART n=7 Participants Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

Timeframe: 48 weeks

Percentage of subjects with HIV-1 viral load \< 50 copies/ml

Outcome measures
Measure	Open Label ART n=7 Participants Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart
Viral Load	4 Participants

Timeframe: 48 weeks

Time to attainment of virologic suppression

Outcome measures
Measure	Open Label ART n=7 Participants Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart
Viral Suppression	6 weeks

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events
Measure	Open Label ART n=7 participants at risk Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart
Cardiac disorders Thrombocytopenia	14.3% 1/7 • Number of events 1 • 48 weeks
Gastrointestinal disorders Gunshot Wound	14.3% 1/7 • Number of events 1 • 48 weeks

Other adverse events
Measure	Open Label ART n=7 participants at risk Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart
General disorders Fatigue	14.3% 1/7 • Number of events 1 • 48 weeks
General disorders Light headedness	14.3% 1/7 • Number of events 1 • 48 weeks
General disorders Mouth ulcers	14.3% 1/7 • Number of events 1 • 48 weeks
Infections and infestations Dental Infection	14.3% 1/7 • Number of events 1 • 48 weeks
General disorders Syncopal Episode	14.3% 1/7 • Number of events 1 • 48 weeks
Renal and urinary disorders Kidney Stones	14.3% 1/7 • Number of events 1 • 48 weeks

University of Maryland, Baltimore, IHV

Phone: 410-706-1660