HIV Infections
Conditions
Keywords
HIV-1, CD4, Viral Load, Human Immunodeficiency Virus (HIV)
Brief summary
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 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.
Detailed description
Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load \< 50 copies/ml).
Interventions
DRUGRaltegravir 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
Sponsors
Merck Sharp & Dohme LLC
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm treatment study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load | 48 weeks | Percentage of subjects with HIV-1 viral load \< 50 copies/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | 48 weeks | Time to attainment of virologic suppression |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label ART Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.
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 | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Open Label ART |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 40 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 6 / 7 |
| serious Total, serious adverse events | 2 / 7 |
Outcome results
Primary
Viral Load
Percentage of subjects with HIV-1 viral load \< 50 copies/ml
Time frame: 48 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label ART | Viral Load | 4 Participants |
Secondary
Viral Suppression
Time to attainment of virologic suppression
Time frame: 48 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Label ART | Viral Suppression | 6 weeks |