HIV-1 Infection
Conditions
Keywords
Efavirenz, Raltegravir, Combination antiretroviral therapy
Brief summary
A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.
Detailed description
A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.
Interventions
DRUGRaltegravir
Raltegravir 400mg oral twice daily
DRUGEfavirenz
Efavirenz 600mg oral at bedtime
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are infected with HIV-1 * Patients have not yet received any treatment for HIV * Patients with HIV viral RNA exceeds 5000 copies per ml * Ages at least 20 years
Exclusion criteria
* Patients with acute or decompensated chronic hepatitis * Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range * Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range * Patients with any medical disorder that the use of study medications is contraindicated * Pregnant or breastfeeding women * Patients who are lack of expectation to maintain assigned study medication during study period * Patients who have received therapy with investigational drugs in the previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. | At week 48 of both arms | Virological response to achieve HIV RNA copies \<20 copies/mL at week 48 of both arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. | At week 48 of both arms | Virological response to achieve HIV RNA copies \<400 copies/mL at week 48 of both arms. |
| The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms. | At week 48 of both arms. | The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms. |
| The Proportion of Treatment Failure at Week 48 for Both Arms. | At week 48 of both arms | The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Raltegravir Raltegravir 400mg oral twice daily
Efavirenz: Efavirenz 600mg oral at bedtime | 51 |
| Efavirenz Efavirenz 600mg oral at bedtime
Raltegravir: Raltegravir 400mg oral twice daily | 54 |
| Total | 105 |
Baseline characteristics
| Characteristic | Raltegravir | Efavirenz | Total |
|---|---|---|---|
| Age, Continuous | 31 years | 33 years | 32 years |
| Baseline VL >100,000 copies/mL | 27 Participants | 28 Participants | 55 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 51 Participants | 54 Participants | 105 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 50 Participants | 52 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 54 |
| other Total, other adverse events | 4 / 51 | 10 / 54 |
| serious Total, serious adverse events | 0 / 51 | 0 / 54 |
Outcome results
Primary
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
Virological response to achieve HIV RNA copies \<20 copies/mL at week 48 of both arms.
Time frame: At week 48 of both arms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Raltegravir | The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. | 41 Participants |
| Efavirenz | The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. | 36 Participants |
Secondary
The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.
The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.
Time frame: At week 48 of both arms.
Secondary
The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.
Virological response to achieve HIV RNA copies \<400 copies/mL at week 48 of both arms.
Time frame: At week 48 of both arms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Raltegravir | The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. | 41 Participants |
| Efavirenz | The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. | 36 Participants |
Secondary
The Proportion of Treatment Failure at Week 48 for Both Arms.
The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.
Time frame: At week 48 of both arms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Raltegravir | The Proportion of Treatment Failure at Week 48 for Both Arms. | 2 Participants |
| Efavirenz | The Proportion of Treatment Failure at Week 48 for Both Arms. | 2 Participants |