Phase 4
Completed N=107
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
Source: ClinicalTrials.gov NCT01989910 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. — 41; 36 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. |
41; 36 | — |
| SECONDARY The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. |
41; 36 | — |
| SECONDARY The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms. |
— | — |
| SECONDARY The Proportion of Treatment Failure at Week 48 for Both Arms. |
2; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01989910). 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.