Kaletra in Combination With Antiretroviral Agents (PROTEKT)

• Number of patients with resistance against PI (protease inhibitor) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
• Number of patients with resistance against PI (protease inhibitor) [ Time Frame: Termination ] [ Designated as safety issue: No ]
• Number of patients with resistance against INI (integrase inhibitor) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
• Number of patients with resistance against INI (integrase inhibitor) [ Time Frame: Termination ] [ Designated as safety issue: No ]
• Number of patients with resistance against NNRTI (non-nucleoside reverse transcriptase inhibitor) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
• Number of patients with resistance against NNRTI (non-nucleoside reverse transcriptase inhibitor) [ Time Frame: Termination ] [ Designated as safety issue: No ]
• Number of patients with (partial) resistance to CCR5 antagonists [ Time Frame: Termination ] [ Designated as safety issue: No ]
• Number of patients with (partial) resistance to CCR5 antagonists. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
• Number of patients with (partial) resistance to CCR5 antagonists. [ Time Frame: Termination ] [ Designated as safety issue: No ]
• Change in CD4 T-cell count [ Time Frame: From Week 0 to Week 144 ] [ Designated as safety issue: No ]
  Increases in CD4 (cluster of differentiation 4) T-lymphocyte count is a bio marker for antiretroviral treatment effectiveness in restoring immunological function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts will be assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled visits planned as part of routine care that are captured in this study.

• Change in time to virologic failure [ Time Frame: From week 0 to week 144 ] [ Designated as safety issue: No ]
  Time to virologic failure : The earliest occurrence of (a) HIV (human immunodeficiency virus)-1 RNA (ribonucleic acid) >400 cp/mL confirmed on two consecutive occasions after achieving at least one HIV-1 RNA <50 cp/mL, (b) HIV-1 RNA >400 cp/mL at the final on-study visit if the patient had previously experienced at least one HIV-1 RNA <50 cp/mL but subsequently did not have HIV-1 RNA >400 cp/mL on two consecutive occasions, or (c) Day 1 if the patient never achieved HIV-1 RNA <50 cp/mL during study participation.
• Mean change in HIV-1 RNA viral load. [ Time Frame: From Week 0 to Week 144 ] [ Designated as safety issue: No ]
  The percentage of patients with HIV (human immunodeficiency virus)-1 RNA (ribonucleic acid) viral load (a) <50 cp/mL, (b) <400 cp/mL, and (c) <1,000 cp/mL will be summarized over time for the study as a whole, as well as for the ARV (antiretroviral)-naïve, NNRTI (non-nucleoside reverse transcriptase inhibitor)-experienced, and PI (protease inhibitor)-experienced subgroups. The percentage of patients with HIV-1 RNA viral load below a pre-specified threshold will be summarized over time using both an intent-to-treat (patients with incomplete treatment = failure) and an on-treatment method.

The purpose of this study is to investigate the tolerability of Lopinavir/ritonavir in combination with new substances.

The Primary Objectives is to assess the tolerability of lopinavir/ritonavir in standard clinical setting.

The Secondary Objectives are to characterize the development of viral resistance and to assess the development of CD4 T-lymphocyte cell count.

All medications will be prescribed as per clinical practice. The Rationale is to document the safety, tolerability and clinical outcome of therapy regimens including lopinavir/ritonavir and new substances, such as INIs (integrase inhibitors, CCR5 (C-C chemokine receptor type 5) antagonists and new NNRTIs (non-nucleoside reverse transcriptase inhibitors) as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with lopinavir/ritonavir.

Community sample: Human Immunodeficiency Virus-positive patients

• Drug: lopinavir/ritonavir
  3 capsules 2 x daily or 2 tablets 2 x daily (Protease inhibitor)
  Other Name: ABT-378/r Kaletra
• Drug: Raltegravir
  2 tablets 400 mg 2 x daily (Integrase inhibitor)
  Other Name: Isentress
• Drug: Maraviroc
  2 tablets 150 mg 2 x daily (C-C chemokine receptor type 5)
  Other Name: Celsentri
• Drug: Rilpivirine
  1 tablet 25 mg 1 x daily (Non-nucleoside reverse transcriptase inhibitor)
  Other Name: Edurant
• Drug: Etravirine
  2 tablets 200 mg 2 x daily (Non-nucleoside reverse transcriptase inhibitor)
  Other Name: Intelence

Inclusion Criteria:

- Patients (18 years and older) with Human Immunodeficiency Virus infection, patients on therapy with lopinavir/ritonavir and an integrase inhibitor or non nucleoside reverse transcriptase inhibitor or CCR5 antagonist for at least 12 weeks

Exclusion Criteria:

• Hypersensitivity against Kaletra or other ingredients or integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists.
• Severe liver insufficiency
• No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort