Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients (RAN)
This study has been completed.
Sponsor:
The University of Texas Health Science Center, Houston
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: December 19, 2014
Last verified: December 2014
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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:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Ritonavir
Atazanavir
Tenofovir Disoproxil Fumarate
Atazanavir sulfate
Raltegravir
Truvada
Raltegravir potassium
U.S. FDA Resources
Further study details as provided by The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- Change From Baseline in CD4 Count at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in Log HIV Viral Load at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline in Lipids at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: Yes ]
- Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in Homocysteine at 6 Months [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
| 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 (Adult, Senior) |
| 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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762892
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
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 |
| Study First Received: | September 26, 2008 |
| Results First Received: | December 19, 2014 |
| Last Updated: | December 19, 2014 |
| 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 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 Atazanavir Sulfate Emtricitabine 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 |
ClinicalTrials.gov processed this record on September 27, 2016