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

A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00762892

Acronym

RAN

Enrollment

Registered

2008-09-30

Start date

2009-01-31

Completion date

2013-01-31

Last updated

2015-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Raltegravir, Integrase inhibitor, Protease inhibitor, Naive patients, HIV disease, Lipids, Treatment Naïve

Brief summary

This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.

Detailed description

We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.

Interventions

DRUGRaltegravir and truvada

Raltegravir 400 mg po bid, truvada 1 tab q daily

DRUGAtazanavir, Norvir and Truvada

Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must be HIV-1 positive and naïve to HIV therapy. * Patients must plan to participate and be available for the trial for the 96-week study period. * Patients followed at Thomas Street Clinic. * Patients must be over 18 years old.

Exclusion criteria

* Patients must not be pregnant or plan to become pregnant over the 96-week study period. * Patients cannot be on a proton pump inhibitor. * Patients cannot be undergoing treatment for active tuberculosis. * Renal Insufficiency with a creatinine clearance \< 50 ml/min/1.73 m2 by the MDRD GFR calculation.

Design outcomes

Primary

Measure	Time frame
Change From Baseline in CD4 Count at 48 Weeks	Baseline and 48 weeks
Change From Baseline in Log HIV Viral Load at 48 Weeks	Baseline and 48 weeks

Secondary

Measure	Time frame
Change From Baseline in Lipids at 48 Weeks	Baseline and 48 weeks
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks	Baseline and 48 weeks
Change From Baseline in Homocysteine at 6 Months	Baseline and 48 weeks

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
Raltegravir Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily	14
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	14
Total	28

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	1	0
Overall Study	Incarceration	1	0
Overall Study	Lost to Follow-up	2	5
Overall Study	Pregnancy	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Atazanavir	Raltegravir	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	14 Participants	14 Participants	28 Participants
Age, Continuous	38.8 year STANDARD_DEVIATION 10	40.7 year STANDARD_DEVIATION 11	39.8 year STANDARD_DEVIATION 10.4
Region of Enrollment United States	14 participants	14 participants	28 participants
Sex: Female, Male Female	3 Participants	7 Participants	10 Participants
Sex: Female, Male Male	11 Participants	7 Participants	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	1 / 14	0 / 14