Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients (RAN)
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ClinicalTrials.gov Identifier: NCT00762892 |
Recruitment Status
:
Completed
First Posted
: September 30, 2008
Results First Posted
: January 5, 2015
Last Update Posted
: January 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Raltegravir and truvada Drug: Atazanavir, Norvir and Truvada | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
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
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- Change From Baseline in CD4 Count at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
- Change From Baseline in Log HIV Viral Load at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
- Change From Baseline in Lipids at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
- Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
- Change From Baseline in Homocysteine at 6 Months [ Time Frame: Baseline and 48 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762892
United States, Texas | |
Thomas Street Clinic | |
Houston, Texas, United States, 77009 |
Principal Investigator: | Tanvir K Bell, MD | UT-Houston |
Additional Information:
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 |
First Posted: | September 30, 2008 Key Record Dates |
Results First Posted: | January 5, 2015 |
Last Update Posted: | January 5, 2015 |
Last Verified: | December 2014 |
Keywords provided by Tanvir K. Bell, MD, 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Raltegravir Potassium Emtricitabine Atazanavir Sulfate Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Ritonavir |
Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV Integrase Inhibitors Integrase Inhibitors HIV Protease Inhibitors Protease Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |