A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

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

Conditions

• HIV-1 Infection

Interventions

DRUG

Darunavir

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 \[200 mg per day\])

DRUG

Etravirine

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.

DRUG

Emtricitabine/tenofovir disoproxil fumarate

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

DRUG

Raltegravir

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

DRUG

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

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.

DRUG

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

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).

OTHER

SOC adherence versus SOC+CPI adherence

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• AbbVie

  collaborator INDUSTRY

• Gilead Sciences

  collaborator INDUSTRY

• Janssen Pharmaceuticals

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Dimagi Inc.

  collaborator INDUSTRY

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  lead NETWORK

Principal Investigators

• Beatriz Grinsztejn, MD, PhD · Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz

• Peter Mugyenyi, MB ChB, FRCP, DSc · Joint Clinical Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-22

Primary Completion

2016-11-23

Completion

2018-12-31

Countries

• Brazil
• Haiti
• India
• Kenya
• Malawi
• Peru
• South Africa
• Thailand
• Uganda
• Zimbabwe

Study Locations