N/A
Completed N=98
Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China
HIV-1 Infections
Source: ClinicalTrials.gov NCT01074931 ↗
Enrolled (actual)
98
Serious AEs
8.2%
Results posted
Aug 2011
Primary outcomePrimary: Evolution of the HIV Viral Response — 0; 51; 0; 3 participant
Summary
This post-marketing observational study is conducted for obtaining data on clinical, biological and virological outcomes, compliance and tolerability of using a lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of naïve or experienced patients infected with human immunodeficiency virus type 1 (HIV-1) in China.
Although LPV/r is frequently used world-wide, the evaluation of the outcomes, compliance, and tolerance of anti-HIV strategies in real life is still a major challenge in the management of HIV-infected patients who are on a life-long therapy, especially in China.
This study will help to develop effectiveness and safety profile of the lopinavir/ritonavir containing regimen in Chinese HIV-1 infected patients, provide more choices of anti-HIV-1 strategies to Chinese experts and benefits Chinese HIV-1 infected patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evolution of the HIV Viral Response |
0; 51; 0; 3; 0; 12 | — |
| PRIMARY Evolution of CD4 Count |
101.00; 249.03; 136.67; 285.96; 200.57; 317.10 | — |
| PRIMARY Evolution of the Tolerance Issues |
2; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen |
49; 9; 13; 17; 10; 6 | — |
| SECONDARY Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations |
1; 8; 90; 24; 65; 1 | — |
| SECONDARY The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment |
1; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients infected by HIV-1 who are over 18 years old
- Patients who belong to one of the following cohorts:
- Antiretroviral naïve patients
- Antiretroviral experienced patients, irrespective to their immune and viral status and current antiretroviral therapy
Exclusion Criteria
- Patients who have been treated with lopinavir/ritonavir
- Patients who are being treated or will be treated with drugs at risk of interactions with lopinavir/ritonavir
- Patients who are not tolerant to lopinavir/ritonavir
- Patients who have uncontrolled AIDS defining disease
- Patients participating in another clinical trial
Data sourced from ClinicalTrials.gov (NCT01074931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.