Clinical trial NCT01641367: A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure
Official title: Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1 Infection
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: AbbVie
name: Gilead Sciences
name: Janssen Pharmaceuticals
name: Merck Sharp & Dohme LLC
name: Dimagi Inc.
First posted: 2012-07-16
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: A5288 was an open-label phase IV, prospective interventional, strategy study in resource-limited settings (RLS) for HIV-1 infected participants with triple-class experience or resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-NRTIs (NNRTIs), and protease inhibitors (PIs) and who were failing their current regimen. The use of novel agents and contemporary clinical decision management tools that include standard genotyping and plasma HIV viral load (VL) monitoring were evaluated. The screening genotype results and antiretroviral (ARV) history were used to allocate potential participants to one of four Cohorts (A, B, C or D) and to select an associated ARV regimen based on the Cohort assignment. In brief, individuals assigned to Cohort A continued on the same PI as in their second-line regimen, with the ability to modify NRTIs. Those assigned to Cohort B who were negative for hepatitis B were randomized to receive RAL and DRV/RTV with either the best available NRTIs (Cohort B1) or ETR (Cohort B2). If they were positive for hepatitis B they were assigned to Cohort B3 and received RAL, DRV/RTV and either FTC/TDF or 3TC/TDF. Individuals assigned to Cohort C received RAL and DRV/RTV with the best available NRTIs. Those ineligible for Cohorts A, B or C were assigned to Cohort D and received the best available regimen that included study provided drugs and any locally provided drugs.

At sites where feasible and relevant, the study evaluated an adherence support intervention. This involved a randomized comparison of a cell phone-based adherence support intervention plus local standard-of-care adherence support procedures (CPI+SOC) versus the SOC adherence support procedures.

Participants enrolled to the study in Step 1. If a participant experienced a confirmed virologic failure (defined as two consecutive HIV-1 RNA measures \>= 1000 copies/mL) at/after 22 weeks on their Step 1 regimen, they had another genotype test performed and cohort/regimen selected for Step 2. With the exception of one additional visit 4 weeks after enrollment to Step 2, the visit schedule for Step 2 followed the participant's original Step 1 schedule throughout the remainder of follow up.

Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. During the first 48 weeks after Step 1 enrollment, clinic visits occurred at weeks 4, 12, 24, 36 and 48. After week 48, visits occurred every 12 weeks for adherence, safety and efficacy measures.

Participants had a final step 1/2 visit between November 22, 2016 and February 13, 2017. At the final step 1/2 visit, participants taking RAL, ETR, or DRV who were unable to obtain these drugs locally (e.g., through local treatment programs), and were otherwise eligible, entered Step 3 and continued to receive these drugs through the study for up to 96 additional weeks. Step 3 participants were dispensed ARVs every 12 weeks and had clinical assessments every 24 weeks. The purpose of Step 3 was to assist participants with the transition back to local care.

The primary analysis specified in the protocol and in the Statistical Analysis Plan was to estimate the proportion of participants in the overall study population who were virologically suppressed (HIV-1 RNA ≤200 copies/mL) at week 48 with a 95% confidence interval.

Eligibility criteria: Inclusion Criteria for Step 1:

* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.
* Any previous combination of ARV treatment at any time with at least one regimen that contained one NNRTI and two NRTIs which was replaced with a PI-based regimen because of virologic, immunologic, or clinical treatment failure, or because of toxicity.

NOTE: All potential participants with prior RAL exposure were assigned to either Cohort A or Cohort D.

* At screening, receipt of a PI-based regimen with no regimen change for a minimum of 24 weeks prior to screening.
* Confirmation of VF of current second-line PI-based ART. NOTE A: Failure of the current second-line regimen was defined as two consecutive measurements of plasma HIV-1 RNA ≥1000 copies/mL obtained at least 1 day apart while on the current PI-based regimen. "Current PI-based regimen" and "current regimen" were understood to be the regimen described (ie, the regimen that the candidate was taking when the first VF sample was drawn plus only those modifications allowed).
* CD4+ T-cell count result from a specimen drawn within 103 days prior to study entry
* Laboratory values obtained within 30 days prior to study entry:

  * Absolute neutrophil count (ANC) ≥ 500/mm\^3
  * Hemoglobin ≥7.5 g/dL
  * Platelet count ≥40,000/mm\^3
  * Creatinine ≤2 X upper limit of normal (ULN)
  * Aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT), serum glutamic pyruvic transaminase (SGPT), and alkaline phosphatase ≤5 x ULN
  * Total bilirubin ≤2.5 x ULN
  * Creatinine clearance (CrCl) \>30 mL/min, either measured or estimated by Cockcroft-Gault equation
  * Hepatitis B panel that includes HbsAB, HBcAB, and HBsAG or only HBsAG, with plasma stored for later anti-HBs and anti-HBc.

NOTE A: Candidates who were eligible for cohort B and who were positive for active hepatitis B infection were assigned to sub-cohort B3 at registration/randomization.

NOTE B: Candidates with CrCl \<60 mL/min who were also positive for active hepatitis B infection were not eligible.

* Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, hysterectomy or bilateral salpingectomy or bilateral oophorectomy or tubal ligation) must have had a negative serum or urine pregnancy test prior to the submission of the screening genotype testing sample and again within 48 hours prior to randomization or registration.
* Female participants of reproductive potential must have agreed not to participate in the conception process (ie, active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female participant must have used at least one reliable form of contraceptive. Female participants must have continued to use contraceptives while receiving study treatment and for 6 weeks after stopping study treatment.

Acceptable forms of contraceptives included:

* Condoms (male or female) with or without a spermicidal agent
* Diaphragm or cervical cap with spermicide
* Intrauterine device (IUD)
* Hormonal contraception

Female participants who were not of reproductive potential or whose male partner(s) had documented azoospermia) were not required to use contraceptives. Any statement of self-reported sterility or that of her partner's must have been entered in the source documents.

NOTE: Acceptable documentation of lack of reproductive potential was oral or written documentation from the participant.

* Karnofsky performance score \>/= 70 within 30 days prior to study entry.
* Ability and willingness of potential participant to provide informed consent.
* Willingness of potential participant to adhere to protocol requirements, especially with respect to treatment assignment and ability to obtain non-study provided ART, if needed.
* Ability to take oral study medications.
* No intention of permanent relocation that would preclude attending Step 1 and 2 study follow-up visits.
* Availability of a successful, interpretable resistance genotype report from a DAIDS-approved regional genotyping facility from testing performed on a plasma sample that was collected during screening (ie, at or after the date that a sample is collected to confirm HIV-1 virologic failure) and which was shipped to a regional resistance testing laboratory once documentation of two screening plasma HIV-1 RNA values ≥1000 copies/mL were available.
* Identification of a cohort assignment and ARV regimen for use on study, selected from the recommended options provided by the site investigator, and reviewed and approved by the A5288 Clinical Management Committee (CMC).

Exclusion Criteria for Step 1:

* Pregnancy or breast-feeding.
* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would have interfered with adherence to study requirements.
* Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or was clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.
* Concurrent illness or condition that would compromise the ability to take study medication, follow the protocol, or that would make participation not in the best interest of the participant, per the site investigator.
* Requirement for taking any of the prohibited medications with the selected ARV study regimen, or within 14 days prior to study entry.

NOTE: Study candidates should not have discontinued any component of their ART during screening. The 14-day restriction on prohibited medications did not apply to ARVs.

* Active tuberculosis (TB) or rifampin exposure less than 2 weeks prior to study entry.
* Any exposure to darunavir or etravirine.

Primary outcomes:
measure: Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
timeFrame: 48 weeks after the date of entry
Secondary outcomes:
measure: Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks
timeFrame: 24 weeks after the date of entry
measure: Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks
timeFrame: 72 weeks after the date of entry
measure: Number of Weeks of Follow-up
timeFrame: From study entry through Step 1/2 follow-up
measure: Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Confirmed Virologic Failure by Week 48
timeFrame: From week 24 to Week 48
measure: Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48
timeFrame: From week 24 to Week 48
measure: Time From Study Entry/Randomization to Death
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants Experiencing Death by Week 48
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to the First of Death or Hospitalization.
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Death or Hospitalization by Week 48
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Treatment Modification or Discontinuation by Week 48
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
timeFrame: From study entry to week 48
measure: Time to First Dose Modification Due to Grade 3 or 4 Toxicity
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48
timeFrame: From study entry to week 48
measure: Change From Baseline in CD4+ T-cell Count
timeFrame: Baseline, week 24, 48, and 72
measure: Change From Baseline in Fasting Values of Total Cholesterol
timeFrame: Baseline, week 24, 48 and 72
measure: Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
timeFrame: Baseline, week 24, 48 and 72
measure: Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
timeFrame: Baseline, week 24, 48 and 72
measure: Change From Baseline in Fasting Values of Triglycerides
timeFrame: Baseline, week 24, 48 and 72
measure: Change From Baseline in Fasting Values of Glucose
timeFrame: Baseline, week 24, 48 and 72
measure: Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]
timeFrame: 48 weeks after the date of entry
measure: Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]
timeFrame: 24 weeks after the date of entry
measure: Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]
timeFrame: 72 weeks after the date of entry
measure: Number of Weeks of Follow-up [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up
measure: Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]
timeFrame: From week 24 to Week 48
measure: Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
timeFrame: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]
timeFrame: From week 24 to Week 48
measure: Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]
timeFrame: From study entry to Week 48
measure: Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]
timeFrame: From study entry to Week 48
measure: Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]
timeFrame: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
measure: Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]
timeFrame: From study entry to Week 48
measure: Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
timeFrame: Baseline, week 24, 48, and 72
measure: Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
timeFrame: Baseline, week 24, 48, and 72
measure: Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
timeFrame: Baseline, week 24, 48, and 72
measure: Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
timeFrame: Baseline, week 24, 48, and 72
measure: Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
timeFrame: Baseline, week 24, 48, and 72
measure: Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
timeFrame: Baseline, week 24, 48, and 72
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao CRS (12201)
state: RS
city: Rio de Janeiro
country: Brazil
facility: Instituto de Pesquisa Clinica Evandro Chagas (12101)
city: Port-au-Prince
country: Haiti
facility: Les Centres GHESKIO CRS (30022)
state: Bicentaire
city: Port Au Prince
country: Haiti
facility: GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
city: Pune
country: India
facility: BJ Medical College CRS (31441)
state: Maharashtra
city: Chennai
country: India
facility: Chennai Antiviral Research and Treatment (CART) CRS (11701)
state: Taramani
city: Eldoret
country: Kenya
facility: AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601)
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS (31460)
city: Lilongwe
country: Malawi
facility: Malawi CRS (12001)
city: San Miguel
country: Peru
facility: San Miguel CRS (11302)
state: Lima
city: Lima
country: Peru
facility: Barranco CRS (11301)
city: Johannesburg
country: South Africa
facility: University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101)
state: Gauteng
city: Cape Town
country: South Africa
facility: Family Clinical Research Unit (FAM-CUR) CRS (8950)
state: West Cape
city: Durban
country: South Africa
facility: Durban Adult HIV CRS (11201)
city: Johannesburg
country: South Africa
facility: Soweto ACTG CRS (12301)
city: Bangkok
country: Thailand
facility: 31802 Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
state: Patumwan
city: Chiang Mai
country: Thailand
facility: 31784 Chiang Mai University HIV Treatment CRS
city: Kampala
country: Uganda
facility: JCRC CRS
city: Harare
country: Zimbabwe
facility: UZ-Parirenyatwa CRS (30313)
Study officials:
affiliation: Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz
name: Beatriz Grinsztejn, MD, PhD
role: STUDY_CHAIR
affiliation: Joint Clinical Research Center
name: Peter Mugyenyi, MB ChB, FRCP, DSc
role: STUDY_CHAIR
References:
citation: Avihingsanon A, Hughes MD, Salata R, Godfrey C, McCarthy C, Mugyenyi P, Hogg E, Gross R, Cardoso SW, Bukuru A, Makanga M, Badal-Aesen S, Mave V, Ndege BW, Fontain SN, Samaneka W, Secours R, Van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Munyanga C, Chagomerana M, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC, Grinsztejn B; A5288 Study team. Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial. J Int AIDS Soc. 2022 Jun;25(6):e25905. doi: 10.1002/jia2.25905.
citation: Godfrey C, Hughes MD, Ritz J, Coelho L, Gross R, Salata R, Mngqibisa R, Wallis CL, Mumbi ME, Matoga M, Poongulali S, Van Schalkwyk M, Hogg E, Fletcher CV, Grinsztejn B, Collier AC; A5288 team. Brief Report: Sex Differences in Outcomes for Individuals Presenting for Third-Line Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):203-207. doi: 10.1097/QAI.0000000000002324.
citation: Gross R, Ritz J, Hughes MD, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Godfrey C, Wallis CL, Mellors JW, Mudhune VO, Badal-Faesen S, Grinsztejn B, Collier AC. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digit Health. 2019 May;1(1):e26-e34. doi: 10.1016/S2589-7500(19)30006-8. Epub 2019 May 6.
citation: Grinsztejn B, Hughes MD, Ritz J, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Gross R, Godfrey C, Cardoso SW, Bukuru A, Makanga M, Faesen S, Mave V, Wangari Ndege B, Nerette Fontain S, Samaneka W, Secours R, van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Avihingsanon A, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC; A5288 Team. Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study. Lancet HIV. 2019 Sep;6(9):e588-e600. doi: 10.1016/S2352-3018(19)30146-8. Epub 2019 Jul 29.