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

NCT00762892 | Completed Phase 4 Results

• 1 other identifier: raltegravir atazanavir naive
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Raltegravir

ACTIVE COMPARATOR

Raltegravir in combination with truvada (tenofovir and emtricitabine)

Drug: Raltegravir and truvada

Atazanavir

ACTIVE COMPARATOR

Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)

Drug: Atazanavir, Norvir and Truvada

Interventions

Raltegravir and truvada DRUG

Raltegravir 400 mg po bid, truvada 1 tab q daily

Also known as: Truvada is tenofovir 300 mg and emtricitabine 200 mg

Raltegravir

Atazanavir, Norvir and Truvada DRUG

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

Also known as: Truvada is tenofovir 300 mg and emtricitabine 200 mg

Atazanavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Thomas Street Clinic

Houston, Texas, 77009, United States

Location

Related Links

• open access journal

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Azoles

Limitations and Caveats

Limitations are the relatively small sample size and loss to follow-up. Medical records of patients that were lost to follow up was reviewed to ensure that no SAE occurred. We also attempted multiple times to contact patients.

Results Point of Contact

• Title: Tanvir Bell, MD
• Organization: UT Health Science Center Houston

Tanvir.K.Bell@uth.tmc.edu

713-500-6759

Study Officials

• Tanvir K Bell, MD

  UT-Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 5, 2015
• Results First Posted: January 5, 2015

Record last verified: 2014-12

Locations

US (1)