Acquired Immunodeficiency Syndrome, HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, HIV, AIDS, treatment experienced
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.
Interventions
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Sponsors
Abbott
Rodwick, Barry M., M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologic response defined as viral load reduction of >/= 1 log | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assess time to loss of virologic response | 48 weeks |
| Assess development of resistance mutations in patients who develop rebound | 48 weeks |
| Assess proportion of patients with HIV-1 viral load < 48 copies | 48 weks |
| Assess safety and tolerability | 48 weeks |
| Assess degree of immune reconstitution | 48 weeks |
| Compare serum lipid profile changes | 48 weeks |
Countries
United States
Outcome results
None listed