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

September 26, 2008
May 6, 2013
January 2009
December 2012   (final data collection date for primary outcome measure)
Cd4 count and HIV RNA viral load test [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00762892 on ClinicalTrials.gov Archive Site
Lipids, safety labs, IL6, homocysteine [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
  • 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
  • Active Comparator: Raltegravir
    Raltegravir in combination with truvada (tenofovir and emtricitabine)
    Intervention: Drug: Raltegravir and truvada
  • Active Comparator: Atazanavir
    Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
    Intervention: Drug: Atazanavir, Norvir and Truvada
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00762892
raltegravir atazanavir naive
No
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Merck Sharp & Dohme Corp.
Principal Investigator: Tanvir K Bell, MD UT-Houston
The University of Texas Health Science Center, Houston
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP