Phase 3
N=413
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00537394 ↗Enrolled (actual)
413
Serious AEs
30.0%
Results posted
Aug 2014
Primary outcome: Primary: Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment — 26.0; 29.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enfuvirtide (Drug); Raltegravir (Drug); Darunavir (Drug); Tipranavir (Drug); Etravirine (Drug); Maraviroc (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment |
26.0; 29.8 | — |
| SECONDARY Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality |
3.1; 3.9; 24.7; 25.3; NA; 97.7 | — |
| SECONDARY Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable) |
9.0; 24.0; 31.1; 38.0; 98.0; NA | — |
| SECONDARY Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment |
0; 0; 36; 36; NA; 48 | — |
| SECONDARY Time From Randomization to Confirmed Virological Failure |
12; 12; 12; 12; 48; 48 | — |
| SECONDARY Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml |
122; 117; 112; 106; 107; 109 | — |
| SECONDARY Change in Plasma HIV-1 Viral Load From Baseline to Week 1 |
1.3; 1.4 | — |
| SECONDARY Change in Summarized Quality of Life Score |
0; 5; 0; 0; 0; 0.5 | — |
| SECONDARY Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable) |
25; 26; 30; 26 | — |
| SECONDARY Change in Cardiovascular Risk Score From Baseline |
-0.7; 0.3; 0.1; 0.8; 0.5; 1.1 | — |
| SECONDARY Change in CD4 Count From Baseline |
105.5; 89.5; 140.8; 115.5 | — |
| SECONDARY Time From Treatment Dispensation to Serious Non-AIDS-defining Events |
4.9; 29.3; 60.0; NA | — |
| SECONDARY Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry |
3; 2 | — |
| SECONDARY Change in Fasting Non-HDL Cholesterol From Baseline |
4.1; 20.8; 7.6; 19.8 | — |
| SECONDARY Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure |
18; 13 | — |
Summary
The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new anti-HIV drug regimen for the suppression of HIV.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infection
- Triple-class drug experience or resistance. More information on this criterion can be found in the protocol.
- Currently on a failing PI-containing regimen that includes 2 other ARVs with no regimen change for 8 weeks prior to study screening
- HIV viral load of 1000 copies/ml or more
- Hepatitis B surface antigen negative within 90 days of study entry
- Able to obtain NRTIs and ritonavir and have required ARVs at time of starting study intervention
- Willing to use acceptable forms of contraception
- Parent or legal guardian willing to provide consent, if applicable
- CD4 count result from a specimen drawn within 120 days prior to study entry
- If any previous HIV-1 viral co-receptor tropism result is available, then most recent specimen date and the tropism result of that specimen AND specimen date and tropism result of any test with either X4 or D/M result, if different from the first specimen, must be available
Inclusion Criteria continued:
- Receipt of successful phenotype/genotype resistance results within 105 days prior to study treatment intervention assignment
- Study team identification of a study regimen and at least 2 NRTIs for participant to take
- Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
Exclusion Criteria
- Chronic, active hepatitis B virus infection (hepatitis B surface antigen positive or HBV DNA positive)
- Taking certain medications. More information on this criterion can be found in the protocol.
- Known allergy/sensitivity to components of two or more of the study-provided drugs or their formulations. For maraviroc, this includes hypersensitivity or history of allergy to soy lecithin or peanuts.
- Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study
- Pregnancy or breastfeeding
- Use of any immunomodulator (interferons, interleukins, systemic corticosteroids, or cyclosporine), vaccine, or investigational therapy within 30 days prior to study treatment allocation/assignment
- Require certain medications prohibited with study treatment
- Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study treatment allocation are not excluded.
Data sourced from ClinicalTrials.gov (NCT00537394). 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.