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

Abbott

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV Infections

Treatments: Drug: Lamivudine; Drug: Stavudine; Drug: Lopinavir/Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00004578

285A

M97-720

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

1

Active Comparator group

Description:

Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added.

Treatment:

Drug: Lamivudine

Drug: Lopinavir/Ritonavir

Drug: Stavudine

2

Active Comparator group

Description:

Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.

Treatment:

Drug: Lamivudine

Drug: Lopinavir/Ritonavir

Drug: Stavudine