Trial record 13 of 34 for:    " September 17, 2008":" October 17, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00762892
First received: September 26, 2008
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Raltegravir and truvada
Drug: Atazanavir, Norvir and Truvada
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Cd4 count and HIV RNA viral load test [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipids, safety labs, IL6, homocysteine [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Raltegravir
Raltegravir in combination with truvada (tenofovir and emtricitabine)
Drug: Raltegravir and truvada
Raltegravir 400 mg po bid, truvada 1 tab q daily
Other Name: Truvada is tenofovir 300 mg and emtricitabine 200 mg
Active Comparator: Atazanavir
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Drug: Atazanavir, Norvir and Truvada
Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Other Name: Truvada is tenofovir 300 mg and emtricitabine 200 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762892

Locations
United States, Texas
Thomas Street Clinic
Houston, Texas, United States, 77009
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Tanvir K Bell, MD UT-Houston
  More Information

No publications provided

Responsible Party: Tanvir K. Bell, MD, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00762892     History of Changes
Other Study ID Numbers: raltegravir atazanavir naive
Study First Received: September 26, 2008
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Raltegravir
Integrase inhibitor
Protease inhibitor
Naive patients
HIV disease
Lipids
Treatment Naïve

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Atazanavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
Integrase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014