Conditions: HIV Infections
Keywords: HIV-1 CD4 Viral Load Human Immunodeficiency Virus (HIV)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

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).

Arms:
arm 1: Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.

Interventions: intervention 1: Raltegravir and Maraviroc in combination
Intervention descriptions: intervention 1: 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

Protocol document: