N/A
N=605
Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00876733 ↗Enrolled (actual)
605
Serious AEs
5.6%
Results posted
Jan 2015
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs — 168; 110; 51; 10 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs |
168; 110; 51; 10; 17; 12 | — |
| SECONDARY Changes in the Viral Load After 12 Months From Baseline. |
-3.3; -0.1; -1.9 | — |
| SECONDARY Changes in the Viral Load After 36 Months From Baseline. |
-3.4; -0.2; -2.1 | — |
| SECONDARY Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. |
188.7; 54.6; 82.8; 128.0 | — |
| SECONDARY Changes in the CD4+ Cell Count After 36 Months From Baseline. |
223.7; 2.8; 116.0; 63.5 | — |
| SECONDARY Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline |
25.2; -3.0; 15.8; 16.4 | — |
| SECONDARY Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline |
12.7; 4.2; 10.9; -13.2 | — |
| SECONDARY Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline |
12.1; 2.4; 14.4; 13.6 | — |
| SECONDARY Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline |
7.9; -61.6; -24.0; 16.3 | — |
| SECONDARY Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline |
0.2; -3.6; 0.3; -8.4 | — |
| SECONDARY Changes in the Laboratory Data (ALT) After 12 Months From Baseline |
5.6; 10.2; 7.0; 9.7 | — |
| SECONDARY Changes in the Laboratory Data (AST) After 12 Months From Baseline |
1.7; 4.4; 3.0; 8.3 | — |
| SECONDARY Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline |
32.9; 25.4; 23.7; 9.1 | — |
| SECONDARY Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline |
0.6; 0.3; 0.3; 0.5 | — |
| SECONDARY Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline |
24.1; 2.0; 24.2; 41.1 | — |
| SECONDARY Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline |
11.0; 4.4; 11.1; -19.6 | — |
| SECONDARY Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline |
12.4; 15.8; 23.8; 22.7 | — |
| SECONDARY Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline |
-3.4; -73.7; -17.2; 34.2 | — |
| SECONDARY Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline |
1.6; 0.0; 0.7; -7.2 | — |
| SECONDARY Changes in the Laboratory Data (ALT) After 36 Months From Baseline |
16.2; 4.0; 11.8; 5.2 | — |
| SECONDARY Changes in the Laboratory Data (AST) After 36 Months From Baseline |
7.3; 0.1; 5.5; -2.7 | — |
| SECONDARY Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline |
52.3; 45.0; 50.3; 12.9 | — |
| SECONDARY Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline |
0.7; 0.2; 0.5; -0.1 | — |
Summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).
Eligibility Criteria
Inclusion criteria
- male and female
- 18 years or older
- written informed consent
- The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC
Exclusion criteria
- Pregnant patients
- The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC
Data sourced from ClinicalTrials.gov (NCT00876733). 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.