R5 Integrase Study in HIV-1 Naive Patients
This study is currently recruiting participants.
Verified November 2012 by University of Maryland
Sponsor:
University of Maryland
Collaborator:
Merck
Information provided by (Responsible Party):
Robert Redfield, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01204905
First received: September 16, 2010
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 10 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.
This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Raltegravir and Maraviroc in combination |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by University of Maryland:
Primary Outcome Measures:
- Viral Load [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]Percentage of subjects with HIV-1 viral load < 50 copies/ml
Secondary Outcome Measures:
- Viral Suppression [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]Time to attainment of virologic suppression
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Open Label |
Drug: Raltegravir and Maraviroc in combination
Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 infection
- CD4 count ≥ 350
- RNA > 5,000
- CCR5 tropic virus
- Baseline genotype without significant mutations known to confer antiretroviral drug resistance to currently licensed antiretroviral agents
- Antiretroviral naïve (< 7 days of experience)
- 18-75 years of age
- Subject able to provide informed consent for the study
- Women of child-bearing age agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
Exclusion Criteria:
- Dual/mixed tropic virus,
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal;
- Total bilirubin >1.5 mg/dL,
- Women pregnant or breastfeeding,
- History of malignancy
- Enrollment in an experimental protocol with concomitant use of drugs known to impact or be impacted in terms of pk or drug-drug interactions with either raltegravir or maraviroc. This includes inducers of UGT1A1 ( such as rifampin, phenytoin, Phenobarbital rifabutin, St. John's wart) as well as CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin , nefazodone and telithromycin) and CYP3A inducers (such as rifampin, carbamazepine, Phenobarbital and phenytoin)
- Enrollment in an experimental protocol having received investigational agents(antiretroviral or non-antiretroviral) within 30 days of study enrollment
- Chronic active hepatitis B infection
- Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Subject requires or is anticipated to require any of the prohibited medications noted in the protocol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204905
Contacts
| Contact: Colleen Boyce, RN | 410-706-0100 |
Locations
| United States, Maryland | |
| University of Maryland, Institute of Human Virology | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Colleen Boyce, RN 410-706-0100 | |
| Principal Investigator: Robert Redfield, MD | |
Sponsors and Collaborators
University of Maryland
Merck
Investigators
| Principal Investigator: | Robert R. Redfield, MD | University of Maryland |
More Information
No publications provided
| Responsible Party: | Robert Redfield, MD, Associate Director of the Institute of Human Virology, University of Maryland, Baltimore, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT01204905 History of Changes |
| Other Study ID Numbers: | HP-00045769 |
| Study First Received: | September 16, 2010 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Maryland:
|
HIV-1 CD4 Viral Load Human Immunodeficiency Virus (HIV) |
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 |
ClinicalTrials.gov processed this record on May 16, 2013