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Trial Outcomes & Findings for Raltegravir Therapy for Women With HIV and Fat Accumulation (NCT NCT00656175)

NCT ID: NCT00656175

Last Updated: 2012-12-19

Results Overview

Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm\^2, not cm\^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm\^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2012-12-19

Participant Flow

61 subjects were screened, 39 enrolled, and 37 completed the Week 24 primary endpoint at 5 sites in North America. Of the 37 subjects included in the as-treated analysis, 17 were randomized to immediate-switch (Immediate Group), and 20 to delayed-switch (Delayed Group).

Participant milestones

Participant milestones
Measure
Immediate
Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
Delayed
Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
Overall Study
STARTED
18
21
Overall Study
COMPLETED
17
20
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Immediate
Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
Delayed
Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
Overall Study
Adverse Event
1
0
Overall Study
Transportation issues
0
1

Baseline Characteristics

Raltegravir Therapy for Women With HIV and Fat Accumulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Immediate
n=18 Participants
Immediate switch of PI or NNRTI to Raltegravir
Delayed
n=21 Participants
Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
Total
n=39 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
18 Participants
n=5 Participants
21 Participants
n=7 Participants
39 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
39 years
STANDARD_DEVIATION 47 • n=5 Participants
36 years
STANDARD_DEVIATION 51 • n=7 Participants
37 years
STANDARD_DEVIATION 49 • n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
21 Participants
n=7 Participants
39 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
African-American
9 Participants
n=5 Participants
13 Participants
n=7 Participants
22 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
Race/Ethnicity, Customized
White
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
North America
18 Participants
n=5 Participants
21 Participants
n=7 Participants
39 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm\^2, not cm\^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm\^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.

Outcome measures

Outcome measures
Measure
Immediate
n=17 Participants
Immediate switch of PI or NNRTI to Raltegravir
Delayed
n=20 Participants
Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)
-6.6 cm^2
Interval -15.5 to 17.6
1.8 cm^2
Interval -9.3 to 8.1

Adverse Events

Immediate

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed

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

Dr. Jordan Lake

UCLA CARE Center

Phone: 310-557-9679

Results disclosure agreements

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