Skip to main content
OpenTrials
Completed

NCT Number: NCT00762892

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thomas Street Clinic

Houston, Texas, 77009, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Raltegravir and truvada

Drug

Raltegravir 400 mg po bid, truvada 1 tab q daily

Other names: Truvada is tenofovir 300 mg and emtricitabine 200 mg

Atazanavir, Norvir and Truvada

Drug

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

Other names: Truvada is tenofovir 300 mg and emtricitabine 200 mg

Primary outcomes

  1. Change From Baseline in CD4 Count at 48 Weeks

    Time frame: Baseline and 48 weeks

  2. Change From Baseline in Log HIV Viral Load at 48 Weeks

    Time frame: Baseline and 48 weeks

Secondary outcomes

  1. Change From Baseline in Lipids at 48 Weeks

    Time frame: Baseline and 48 weeks

  2. Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks

    Time frame: Baseline and 48 weeks

  3. Change From Baseline in Homocysteine at 6 Months

    Time frame: Baseline and 48 weeks

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: RAN

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Sep 30, 2008
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.