Trial Outcomes & Findings for Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response (NCT NCT00772590)

NCT ID: NCT00772590

Last Updated: 2012-08-24

Results Overview

Comparison of normalised mean change from baseline CD4+ cell count

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 75 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2012-08-24

Participant Flow

100 patients were screening at 20 clinical sites in Australia

25 of 100 patients screened did not meet study inclusion criteria and were excluded from study

Participant milestones

Measure	Raltegravir + Hyper-immune Bovine Colostrum Raltegravir and hyper-immune bovine colostrum	Hyper-immune Bovine Colostrum Hyper-immune bovine colostrum and Raltegravir placebo	Raltegravir Raltegravir and Hyper-immune Bovine Colostrum placebo	Placebo Raltegravir placebo and hyper-immune bovine colostrum placebo
Overall Study STARTED	19	19	18	17
Overall Study COMPLETED	19	19	18	17
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response

Baseline characteristics by cohort

Measure	Raltegravir + Hyper-immune Bovine Colostrum n=19 Participants Raltegravir and hyper-immune bovine colostrum	Hyper-immune Bovine Colostrum n=19 Participants Hyper-immune bovine colostrum and Raltegravir placebo	Raltegravir n=18 Participants Raltegravir and Hyper-immune Bovine Colostrum placebo	Placebo n=17 Participants Raltegravir placebo and hyper-immune bovine colostrum placebo	Total n=73 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	69 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Age Continuous	52 years STANDARD_DEVIATION 11 • n=5 Participants	56 years STANDARD_DEVIATION 9 • n=7 Participants	50 years STANDARD_DEVIATION 10 • n=5 Participants	55 years STANDARD_DEVIATION 10 • n=4 Participants	53 years STANDARD_DEVIATION 10 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	16 Participants n=4 Participants	69 Participants n=21 Participants
Region of Enrollment Australia	19 participants n=5 Participants	19 participants n=7 Participants	18 participants n=5 Participants	17 participants n=4 Participants	73 participants n=21 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.

Comparison of normalised mean change from baseline CD4+ cell count

Outcome measures

Measure	Raltegravir + Hyper-immune Bovine Colostrum n=19 Participants Raltegravir and hyper-immune bovine colostrum	Hyper-immune Bovine Colostrum n=19 Participants Hyper-immune bovine colostrum and Raltegravir placebo	Raltegravir n=18 Participants Raltegravir and Hyper-immune Bovine Colostrum placebo	Placebo n=17 Participants Raltegravir placebo and hyper-immune bovine colostrum placebo
Mean Change From Baseline CD4+ Cell Count	8.62 Cells/microlitre Standard Deviation 32.19	2.68 Cells/microlitre Standard Deviation 35.8	8.68 Cells/microlitre Standard Deviation 44.58	21.87 Cells/microlitre Standard Deviation 34.8

Adverse Events

Raltegravir + Hyper-immune Bovine Colostrum

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Hyper-immune Bovine Colostrum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Raltegravir

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Raltegravir + Hyper-immune Bovine Colostrum n=19 participants at risk Raltegravir and hyper-immune bovine colostrum	Hyper-immune Bovine Colostrum n=19 participants at risk Hyper-immune bovine colostrum and Raltegravir placebo	Raltegravir n=18 participants at risk Raltegravir and Hyper-immune Bovine Colostrum placebo	Placebo n=17 participants at risk Raltegravir placebo and hyper-immune bovine colostrum placebo
Skin and subcutaneous tissue disorders Hosp. For cellulitis	0.00% 0/19 • Baseline to week 24	0.00% 0/19 • Baseline to week 24	5.6% 1/18 • Baseline to week 24	0.00% 0/17 • Baseline to week 24
Respiratory, thoracic and mediastinal disorders Hosp. for possible Influenza A	0.00% 0/19 • Baseline to week 24	0.00% 0/19 • Baseline to week 24	0.00% 0/18 • Baseline to week 24	5.9% 1/17 • Baseline to week 24
Cardiac disorders Hosp. for chest pain	5.3% 1/19 • Baseline to week 24	0.00% 0/19 • Baseline to week 24	0.00% 0/18 • Baseline to week 24	0.00% 0/17 • Baseline to week 24

Other adverse events

Adverse event data not reported

Additional Information

Sean Emery

Kirby Institute, University of New South Wales

Phone: +612 938509900

Email: semery@kirby.unsw.edu.au

Results disclosure agreements

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