CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 545 enrolled
Drug / intervention
Darunavir +6 moredrug
Likely dose
Darunavir 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01641367
NCT01641367Phase 4Completed
CompareCT.gov

Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jul 16, 2012·Updated Mar 15, 2019

In Brief

A Phase 4 clinical trial evaluating Darunavir, Etravirine, and 5 other interventions for HIV-1 Infection. Completed, enrolled 545 participants across 19 sites in 10 countries.

Detailed Summary

The study was done to: * test a strategy of using a resistance test to choose anti-HIV drugs * see how well combinations of new anti-HIV drugs work to lower HIV infection * see if taking new anti-HIV drugs together is safe and tolerable * see if text messages improve people's anti-HIV drug-taking behavior (only at sites participating in the adherence study) * in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare how these drugs act in the body * to see how people do after they stop having frequent clinic visits as part of a research study

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesBrazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, Zimbabwe
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), AbbVie, Gilead Sciences, Janssen Pharmaceuticals, Merck Sharp & Dohme LLC, Dimagi Inc.

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2012
Enrollment StartFeb 22, 2013
Primary CompletionNov 23, 2016
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.0 years ago

Interventions

Darunavirdrug

Participants were administered darunavir orally as one 600 mg tablet twice a day (1200 mg per day) with food (taken with Ritonavir 100 mg twice a day \[200 mg per day\])

Etravirinedrug

Patients were administered Etravirine orally as two 100 mg tablets or one 200 mg tablet twice a day (400 mg per day) following a meal.

Emtricitabine/tenofovir disoproxil fumaratedrug

Patients were administered FTC/TDF orally as one fixed dose combination tablet (FTC 200 mg/TDF 300 mg) once daily, with or without food.

Raltegravirdrug

Participants were administered Raltegravir orally as one 400 mg tablet twice daily (800 mg per day), with or without food

Second line ART regimens - based on a boosted protease inhibitor (bPI) plus two nucleoside analogues (NRTIs)drug

LPV/r and ATV/r were the preferred bPIs for second-line ART. TDF + (3TC or FTC) or AZT + 3TC were the most frequent NRTI backbones. Cohort A did not include any of the new drugs; therefore, it is distinct from Cohorts B, C, and D.

Study provided drugs according to patient resistance profile (DRV, ETR, RTV, FTC/TDF) + any in country available drug as applicable & availabledrug

For Cohort D, in many situations a participant received the same regimen that patients are getting in Cohorts B and C if that was the best combination that can be obtained according to his/her resistance profile and drug availability (as for many countries there were no further drug options beyond the available study drugs).

SOC adherence versus SOC+CPI adherenceother

* not participating in the adherence randomization; OR * randomized to SOC adherence; OR * randomized to SOC+CPI adherence.