Trial Outcomes & Findings for Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals (NCT NCT00632970)

NCT ID: NCT00632970

Last Updated: 2018-08-29

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 6 participants
• Primary outcome timeframe: 24 and 48 weeks
• Results posted on: 2018-08-29

Participant Flow

Participant milestones

Measure	Raltegravir Patients with HIV infection randomized to receive raltegravir with truvada	Lopinavir/Ritonavir Patients with HIV infection randomized to receive lopinavir/ritonavir with truvada
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

Baseline characteristics by cohort

Measure	Raltegravir n=3 Participants Raltegravir: 1 400mg tablet twice a day	Lopinavir/Ritonavir n=3 Participants Lopinavir/Ritonavir: 2 tablets twice a day	Total n=6 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	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants 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	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
HIV seropositive with viral load < 10,000	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 and 48 weeks

Outcome measures

Measure	Raltegravir n=3 Participants Raltegravir: 1 400mg tablet twice a day	Lopinavir/Ritonavir n=3 Participants Lopinavir/Ritonavir: 2 tablets twice a day
Absolute Change in CD4 Cell Counts	50 cells/mm^3 Interval 10.0 to 150.0	50 cells/mm^3 Interval 20.0 to 120.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Data can not be reported because the samples were never analyzed and therefore no data was analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lopinavir/Ritonavir

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

Gary Simon

Medical Faculty Associates

Phone: 202 741-2234

Email: Gsimon@mfa.gwu.edu

Results disclosure agreements

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