Phase 2
Completed N=112
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
HIV-1 Infections
Source: ClinicalTrials.gov NCT00830804 ↗
Enrolled (actual)
112
Serious AEs
11.6%
Results posted
Oct 2011
Primary outcomePrimary: Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24 — 0.16 Proportion of participants
Summary
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24 |
0.16 | — |
| SECONDARY Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24 |
0.21 | — |
| SECONDARY Change in Plasma HIV-1 RNA From Baseline to Week 1 |
-1.67 | — |
| SECONDARY Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24 |
0.79; 0.93 | — |
| SECONDARY Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48 |
0.71; 0.86 | — |
| SECONDARY Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment |
0.20 | — |
| SECONDARY Number of Participants With Pretreatment Drug Resistance |
9; 8; 1; 2; 1; 91 | — |
| SECONDARY Number of Participants With Integrase Drug Resistance at Virologic Failure |
5 | — |
| SECONDARY Number of Participants With Protease Drug Resistance at Virologic Failure |
— | — |
| SECONDARY Number of Participants With Perfect Overall Adherence by Self Report |
95 | — |
| SECONDARY Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 |
31.5; 6.5; 24.5 | — |
| SECONDARY Change in Fasting Low-density Lipoprotein at Week 24 |
16.0 | — |
| SECONDARY Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 |
30; 9; 23 | — |
| SECONDARY Change in Fasting Low-density Lipoprotein at Week 48 |
17 | — |
| SECONDARY Change in CD4 Count at Week 48 |
200 | — |
| SECONDARY Plasma Trough Concentration of Raltegravir |
117 | — |
| SECONDARY Plasma Trough Concentration of Darunavir |
1218 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1-infected
- Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry
- HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.
- ARV drug-naive. More information on this criterion can be found in the protocol.
- Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
- Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.
Exclusion Criteria
- Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.
- Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation [RAM] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone
- Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S
- Severe renal insufficiency requiring hemodialysis or peritoneal dialysis
- Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.
- Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.
- Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.
- Certain abnormal laboratory results. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00830804). 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.