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R5 Integrase Study in HIV-1 Naive Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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

September 16, 2010
November 8, 2012
September 2010
December 2013   (final data collection date for primary outcome measure)
Viral Load [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
Percentage of subjects with HIV-1 viral load < 50 copies/ml
Same as current
Complete list of historical versions of study NCT01204905 on ClinicalTrials.gov Archive Site
Viral Suppression [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
Time to attainment of virologic suppression
Same as current
Not Provided
Not Provided
 
R5 Integrase Study in HIV-1 Naive Patients
Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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:
  • Raltegravir (Isentress)
  • Maraviroc(Selzentry)
Open Label
Intervention: Drug: Raltegravir and Maraviroc in combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
September 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Colleen Boyce, RN 410-706-0100
United States
 
NCT01204905
HP-00045769
Yes
Robert Redfield, MD, University of Maryland
University of Maryland
Merck Sharp & Dohme Corp.
Principal Investigator: Robert R. Redfield, MD University of Maryland
University of Maryland
November 2012

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