Pilot Assessment of Lopinavir/Ritonavir and Maraviroc
Phase 4
Terminated
- Conditions
- HIV InfectionsAcquired Immunodeficiency Syndrome
- Interventions
- Registration Number
- NCT00981318
- Lead Sponsor
- Rodwick, Barry M., M.D.
- Brief Summary
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.
- Detailed Description
As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- HIV viral load > 1,000 on current antiviral medications
- No resistance to study medications
- Over 18 years of age
Exclusion Criteria
- Hepatitis B co-infection
- Pregnancy
- Previous therapy with either of the study medications
- Ongoing substance abuse
- Significant history of other physical disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid lopinavir/ritonavir plus maraviroc single arm
- Primary Outcome Measures
Name Time Method Virologic response defined as viral load reduction of >/= 1 log 48 weeks
- Secondary Outcome Measures
Name Time Method Assess proportion of patients with HIV-1 viral load < 48 copies 48 weks Assess time to loss of virologic response 48 weeks Assess development of resistance mutations in patients who develop rebound 48 weeks Compare serum lipid profile changes 48 weeks Assess safety and tolerability 48 weeks Assess degree of immune reconstitution 48 weeks
Trial Locations
- Locations (1)
Barry M. Rodwick, M. D.
🇺🇸Safety Harbor, Florida, United States