ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

Study Overview
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Brief Summary
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To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.

Official Title
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Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Lopinavir/Ritonavir
* Drug: Lamivudine
* Drug: Stavudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added. | Drug: Lopinavir/Ritonavir<br>* Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs<br>* Other names: Kaletra;Drug: Lamivudine<br>* 150 mg, every 12 hours<br>Drug: Stavudine<br>* 40 mg every 12 hours<br>|
| Active Comparator: 2<br>Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed. | Drug: Lopinavir/Ritonavir<br>* Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs<br>* Other names: Kaletra;Drug: Lamivudine<br>* 150 mg, every 12 hours<br>Drug: Stavudine<br>* 40 mg every 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with viral load below the limit of quantitation |  | 24 weeks | 
| Time to loss of virologic response |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with viral load below the limit of quantitation at each visit |  | At each visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Reverse Transcriptase Inhibitors