Trial Outcomes & Findings for Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients (NCT NCT00762892)

NCT ID: NCT00762892

Last Updated: 2015-01-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline and 48 weeks
• Results posted on: 2015-01-05

Participant Flow

approached patients HIV positive, naive to therapy, single site, English and Spanish speaking/writing.

Participant milestones

Measure	Raltegravir Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Overall Study STARTED	14	14
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Raltegravir Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Overall Study Lost to Follow-up	2	5
Overall Study Withdrawal by Subject	0	1
Overall Study Death	1	0
Overall Study Pregnancy	1	0
Overall Study Incarceration	1	0

Baseline Characteristics

Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients

Baseline characteristics by cohort

Measure	Raltegravir n=14 Participants Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir n=14 Participants Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	40.7 year STANDARD_DEVIATION 11 • n=93 Participants	38.8 year STANDARD_DEVIATION 10 • n=4 Participants	39.8 year STANDARD_DEVIATION 10.4 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	11 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	14 participants n=4 Participants	28 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 48 weeks

Outcome measures

Measure	Raltegravir n=9 Participants Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir n=8 Participants Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Change From Baseline in CD4 Count at 48 Weeks	192 cells/uL Standard Deviation 26	205 cells/uL Standard Deviation 27

PRIMARY outcome

Timeframe: Baseline and 48 weeks

Outcome measures

Measure	Raltegravir n=9 Participants Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir n=8 Participants Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Change From Baseline in Log HIV Viral Load at 48 Weeks	-3.05 copies/mL Standard Deviation 0.28	-3.29 copies/mL Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Outcome measures

Measure	Raltegravir n=9 Participants Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir n=8 Participants Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Change From Baseline in Lipids at 48 Weeks Total cholesterol	-0.25 mg/dL Standard Deviation 7.66	8.13 mg/dL Standard Deviation 11.96
Change From Baseline in Lipids at 48 Weeks Triglycerides	-15.50 mg/dL Standard Deviation 18.47	16.88 mg/dL Standard Deviation 40.89
Change From Baseline in Lipids at 48 Weeks HDL cholesterol	-1.5 mg/dL Standard Deviation 2.58	-1.38 mg/dL Standard Deviation 3.08
Change From Baseline in Lipids at 48 Weeks LDL cholesterol	4.13 mg/dL Standard Deviation 7.54	5.88 mg/dL Standard Deviation 14.46

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Outcome measures

Measure	Raltegravir n=9 Participants Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir n=8 Participants Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks	-2.71 pg/mL Standard Deviation 1.63	-4.47 pg/mL Standard Deviation 2.51

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Outcome measures

Measure	Raltegravir n=9 Participants Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir n=8 Participants Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Change From Baseline in Homocysteine at 6 Months	0.53 umol/L Standard Deviation 0.83	0.10 umol/L Standard Deviation 0.94

Adverse Events

Raltegravir

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Atazanavir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Raltegravir n=14 participants at risk Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	Atazanavir n=14 participants at risk Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Renal and urinary disorders MAI infection, multi-organ failure, death	7.1% 1/14 • Number of events 1	0.00% 0/14

Other adverse events

Adverse event data not reported

Additional Information

Tanvir Bell, MD

UT Health Science Center Houston

Phone: 713-500-6759

Email: Tanvir.K.Bell@uth.tmc.edu

Results disclosure agreements

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