N/A
N=151
Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT01190124 ↗Enrolled (actual)
151
Serious AEs
2.0%
Results posted
May 2011
Primary outcome: Primary: HIV-RNA Levels — 0; 24; 10; 107 participants — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Doroana, Maria Manuela, M.D.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV-RNA Levels |
16; 3; 1 | — |
| PRIMARY HIV-RNA Levels |
16; 3; 1 | — |
| PRIMARY HIV-RNA Levels |
16; 3; 1 | — |
| PRIMARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| PRIMARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| PRIMARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| SECONDARY HIV-RNA Levels |
16; 3; 1 | — |
| SECONDARY HIV-RNA Levels |
16; 3; 1 | — |
| SECONDARY HIV-RNA Levels |
16; 3; 1 | — |
| SECONDARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| SECONDARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| SECONDARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| SECONDARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| SECONDARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| SECONDARY CD4 Cells Count |
336.50; 452.00; 180.00 | 0.001 sig |
| SECONDARY HIV-RNA Levels |
16; 3; 1 | — |
| SECONDARY HIV-RNA Levels |
16; 3; 1 | — |
| SECONDARY HIV-RNA Levels |
16; 3; 1 | — |
| SECONDARY Adverse Drug Reactions |
12; 9; 3; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy of raltegravir with optimized background therapy (OBT) in multiple-experienced HIV infected patients, measured by the proportion of patients with undetectable viral load and the mean increase of CD4 cells count at week 24 and 48.
It is also intended to evaluate:
* viral load suppression and the mean increase of CD4 cells count at week 24 and 48 in patients who needed to change antiretroviral (ARV) therapy due to inacceptable toxicity, as determined by the investigator, including patients who needed to replace T20.
* efficacy of raltegravir with OBT in HIV-2 infected patients that were included in this cohort, measured by the percentage of patients with undetectable viral load and the mean change of CD4 cells count at week 24 and 48.
Study hypotheses:
* Raltegravir with OBT is effective in achieving and maintaining a long term virologic suppression along with a significant increase on CD4 cells count in both HIV-1 and HIV-2 infected patients.
* Patients who replaced T20 by raltegravir, due to intolerance, are able to maintain long term virologic suppression.
Eligibility Criteria
Inclusion Criteria
- Male or female patients, aged 18 years or older
- ARV multi-experienced patients (i.e. experienced at least two prior regimens) with need to change current ARV therapy, including:
- HIV-1 infected patients with documented therapeutic failure,
- HIV-2 infected patients with documented therapeutic failure
- HIV infected patients in virologic suppression who needed to change ARV due to inacceptable toxicity, as determined by the investigator, including patients who needed to replace T20
- Raltegravir-naïve patients who initiated raltegravir since the EAP Program, with optimized background therapy(OBT)
- Patient who has been followed at the same clinical site since the start of raltegravir
Exclusion Criteria
- Acute or decompensated chronic hepatitis. Patients with serum aminotransferase levels 10 times the upper limit of the normal range or higher (grade 4)
- Patients who presented resistance to drugs included in OBT (namely, etravirine, darunavir or maraviroc)
- Non-existing medical records for viral load and TCD4 at baseline, week 24 and 48
Data sourced from ClinicalTrials.gov (NCT01190124). 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.