R5 Integrase Study in HIV-1 Naive Patients
|ClinicalTrials.gov Identifier: NCT01204905|
Recruitment Status : Unknown
Verified November 2012 by Robert Redfield, MD, University of Maryland.
Recruitment status was: Recruiting
First Posted : September 17, 2010
Last Update Posted : November 9, 2012
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 or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Raltegravir and Maraviroc in combination||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||September 2014|
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
- Viral Load [ Time Frame: 48 months ]Percentage of subjects with HIV-1 viral load < 50 copies/ml
- Viral Suppression [ Time Frame: 48 months ]Time to attainment of virologic suppression
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): NCT01204905
|Contact: Colleen Boyce, RN||410-706-0100|
|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|
|Principal Investigator:||Robert R. Redfield, MD||University of Maryland|