HIV Infections
Conditions
Keywords
Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Reverse Transcriptase Inhibitors
Brief summary
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
Interventions
DRUGLopinavir/Ritonavir
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
DRUGLamivudine
150 mg, every 12 hours
DRUGStavudine
40 mg every 12 hours
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 positive * antiretroviral-adult males * non-pregnant * non-lactating females at least 18-years old with plasma HIV-1 RNA \> 5000 copies/mL, who were not acutely ill
Exclusion criteria
* History of: * prior antiretroviral therapy * significant drug hypersensitivity * psychiatric illness that precludes compliance * an active substance abuser * positive test results for drug abuse * abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results * pregnancy or lactating female * received another investigational drug within 28 days of study initiation * unlikely to comply or unsuitable candidate in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with viral load below the limit of quantitation | 24 weeks |
| Time to loss of virologic response | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with viral load below the limit of quantitation at each visit | At each visit |
Countries
United States
Outcome results
None listed