Phase 4
N=541
A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00931463 ↗Enrolled (actual)
541
Serious AEs
8.7%
Results posted
Jan 2014
Primary outcome: Primary: Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization — 219; 223 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- raltegravir (Drug); 2N(t)RTI (Drug); Ritonavir-boosted lopinavir (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Kirby Institute
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization |
219; 223 | — |
| SECONDARY Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population |
211; 211 | — |
| SECONDARY Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure |
208; 210 | — |
| SECONDARY Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL |
31; 39 | — |
| SECONDARY Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL |
188; 184 | — |
Summary
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir.
The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.
The primary endpoint is virological: a comparison of virological suppression in plasma < 200 copies/mL between the randomized arms after 48 weeks.
Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.
Eligibility Criteria
Inclusion Criteria
- HIV-1 positive by licensed diagnostic test
- Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)
- Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for at least 24 weeks
- No change in antiretroviral therapy within 12 weeks prior to screening
- Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (at least 7 days apart) HIV RNA results of greater then 500 copies/mL
- No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors
- Able to provide written informed consent
Exclusion Criteria
- The following laboratory variables:
- absolute neutrophil count (ANC) < 500 cells/microlitres
- hemoglobin < 7.0 g/decilitres
- platelet count < 50,000 cells/microlitres
- ALT great than 5 x ULN
- Pregnant or nursing mothers
- Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
- Use of immunomodulators within 30 days prior to screening
- Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
- Intercurrent illness requiring hospitalization
- Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
- Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
- Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
Data sourced from ClinicalTrials.gov (NCT00931463). 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.