IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women

NCT00955968 | Completed Phase 4 Results DMC

• 2 other identifiers: IMPAACT 1077HSU01AI068632
• Study Type: interventional
• Target: 1,653
• Locations: 9 countries
• Sites: 50

Brief Summary

This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.

Conditions

HIV Infection

Keywords

HIV Infection; HAART; Maternal Health

Outcome Measures

Primary Outcomes (1)

• Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death

  AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.

  From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Secondary Outcomes (19)

• Incidence Rate of AIDS - Defining Illness

  From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

• Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event

  From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

• Incidence Rate of Deaths

  From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

• Incidence Rate of HIV/AIDS Related Events

  From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

• Incidence Rate of HIV/AIDS Related Events or Death

  From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Study Arms (2)

Continue HAART

EXPERIMENTAL

Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.

Drug: Highly active antiretroviral therapy (HAART)

Stop HAART

ACTIVE COMPARATOR

Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.

Drug: Highly active antiretroviral therapy (HAART)

Interventions

Highly active antiretroviral therapy (HAART) DRUG

A combination of three or more HIV medications belonging to two or more drug classes. The preferred study-supplied HAART regimen was lopinavir/ritonavir (LPV/RTV) plus fixed dose combination tenofovir/emtricitabine (TDF/FTC). Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose combination tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV), didanosine (ddI), atazanavir (ATV), raltegravir (RAL), and ritonavir (RTV). While LPV/RTV plus TDF/FTC was the preferred study-supplied regimen, the study clinicians in conjunction with participants would determine the optimal drug combination for each participant.

Continue HAART; Stop HAART

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age ≥ 18 years or who had attained the minimum age of independent consent, as defined by the local Institutional Review Board (IRB), and were willing and able to provide written informed consent Additionally, at sites with IRB approval to enroll younger participants, women age 16-17 years who were willing and able to provide written assent and whose parent or legal guardian was willing and able to provide written informed consent
• Confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry, using protocol-specified tests (see protocol for more details)
• Documentation of hepatitis B surface antibody (HBsAb) status and hepatitis B surface antigen (HBsAg) status (if antibody was negative) within 12 months prior to study entry
• Within 0-42 days after pregnancy outcome
• Antiretroviral treatment naïve, defined as \< 14 days of one or more antiretroviral agents, prior to therapy initiated during current pregnancy
• Receipt of at least four weeks of HAART prior to study entry, at least two weeks of which must have been prior to pregnancy outcome (up to seven consecutive days of missed therapy is permitted)
• CD4+ cell count ≥ 400 cells/mm\^3 on a specimen obtained within 120 days prior to initiation of HAART for current pregnancy
• CD4+ cell count ≥ 400 cells/mm\^3 on a specimen obtained on HAART and within 45 days prior to study entry
• The following laboratory values on a specimen obtained within 45 days prior to study entry:
• Absolute neutrophil count ≥ 750/mm\^3
• Hemoglobin ≥ 7.0 g/dL
• Platelet count ≥ 50,000/mm\^3
• AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 2.5 x ULN
• Estimated creatinine clearance of ≥ 60mL/min within 45 days prior to entry using the Cockcroft-Gault formula
• Intent to remain in current geographical area of residence for the duration of the study

You may not qualify if:

• Previous participation in PROMISE (P1077BF - NCT01061151)
• Clinically significant illness or condition requiring systemic treatment and/or hospitalization within 30 days prior to study entry
• Social or other circumstances which, in the opinion of the site investigator, would hinder long-term follow up
• Use of any prohibited medications within 14 days prior to study entry (refer to the study MOP for a list of prohibited medications)
• Current compulsory detention (involuntary incarceration) in a correctional facility, prison, or jail for legal reasons or compulsory detention in a medical facility for treatment of either a psychiatric or physical (e.g., infectious disease) illness
• Currently breastfeeding or planning to breastfeed
• Known evidence of HBV DNA levels \>2000 IU/mL (approximately 10,000 copies/mL) in the presence of elevated (grade 1 and higher) ALT (HBV DNA testing was not required for study screening or enrollment but was considered to determine whether treatment for HBV was indicated)

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (50)

University of Southern California MCA Center (5048)

Alhambra, California, 90007, United States

Location

David Geffen School of Medicine at UCLA (5112)

Los Angeles, California, 90095, United States

Location

UCSD Mother-Child-Adolescent HIV Program (4601)

San Diego, California, 92093, United States

Location

Harbor (UCLA) Medical Center (5045)

Torrance, California, 90505, United States

Location

University of Colorado (5052)

Aurora, Colorado, 80045, United States

Location

Howard University (5044)

Washington D.C., District of Columbia, 20059, United States

Location

Georgetown University (1008)

Washington D.C., District of Columbia, United States

Location

Washington Hospital Center (5023)

Washington D.C., District of Columbia, United States

Location

Children's Diagnostic and Treatment Center (5055)

Fort Lauderdale, Florida, United States

Location

University of Florida at Jacksonville (5051)

Jacksonville, Florida, United States

Location

University of Miami Pediatric/Perinatal Clinical Research Site (4201)

Miami, Florida, United States

Location

University of South Florida at Tampa (5018)

Tampa, Florida, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago (4001)

Chicago, Illinois, United States

Location

Tulane University (5095)

New Orleans, Louisiana, United States

Location

Johns Hopkins University School of Medicine (5092)

Baltimore, Maryland, 21287, United States

Location

Boston Medical Center (5011)

Boston, Massachusetts, United States

Location

Wayne State University/Children's Hospital of Michigan (5041)

Detroit, Michigan, United States

Location

Metropolitan Hospital (5003)

New York, New York, 10029, United States

Location

SUNY Stony Brook University Medical Center (5040)

Stony Brook, New York, United States

Location

Bronx-Lebanon Hospital Center (5114)

The Bronx, New York, United States

Location

Jacobi Medical Center (5013)

The Bronx, New York, United States

Location

Duke University Medical Center (4701)

Durham, North Carolina, United States

Location

Pitt CRS (1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

St Jude Children's Research Hospital (6501)

Memphis, Tennessee, United States

Location

Baylor College of Medicine Texas Children's Hospital (3801)

Houston, Texas, United States

Location

Seattle Children's Hospital (5017)

Seattle, Washington, United States

Location

Hospital General de Agudos (5082)

Buenos Aires, Argentina

Location

Gaborone Prevention/Treatment Clinical Research Site (12701)

Gaborone, Botswana

Location

Molepolole Prevention/Treatment Clinical Research Site (12702)

Gaborone, Botswana

Location

School of Medicine, University of Minas Gerais - FUNDEP (5073)

Belo Horizonte, Brazil

Location

University Caxias do Sul (5084)

Caxias do Sul, Brazil

Location

Hospital Nossa Senhora da Conceicao (5117)

Porto Alegre, Brazil

Location

Hospital Santa Casa (5098)

Porto Alegre, Brazil

Location

Hospital dos Servidores do Estado (5072)

Rio de Janeiro, Brazil

Location

Hospital Geral De Nova Igaucu (5097)

Rio de Janeiro, Brazil

Location

Instituto de Puericultura E Pediatria Martagao Geseira - FUJB (5071)

Rio de Janeiro, Brazil

Location

Ribeirao Preto Medical School, University of Sao Paulo (5074)

São Paulo, Brazil

Location

Guangxi Center for HIV/AIDS Prevention and Control (30274)

Nanning, Guangxi, China

Location

Les Centres GHESKIO (30022)

Port-au-Prince, Haiti

Location

IMPACTA Barranco Clinical Research Site (11301)

Lima, Peru

Location

IMPACTA San Miguel Clinical Research Site (11302)

Lima, Peru

Location

San Juan City Hospital (5031)

San Juan, 00927, Puerto Rico

Location

University of Puerto Rico Pediatric HIV/AIDS Research Program (6601)

San Juan, Puerto Rico

Location

Siriraj Hospital Mahidol University CRS (5115)

Bangkok, Ratchathewi,, 10700, Thailand

Location

Bhumibol Adulyadej Hospital (5124)

Bangkok, Thailand

Location

Prapokklao Hospital (5123)

Chanthaburi, 22000, Thailand

Location

Chiang Mai University (31784)

Chiang Mai, 50200, Thailand

Location

Chiang Rai Regional Hospital (5116)

Chiang Rai, Thailand

Location

Chonburi Hospital (5125)

Chon Buri, 20000, Thailand

Location

Phayao Provincial Hospital (5122)

Phayao, 56000, Thailand

Location

Related Publications (3)

• U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 with Clarification dated August 2009, which can be found on the DAIDS RSC Web site: http://rsc.tech-res.com

  BACKGROUND

• Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0, January 2010.

  BACKGROUND

• Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, Santos B, Aurpibul L, Losso M, Pierre MF, Weinberg A, Gnanashanmugam D, Chakhtoura N, Klingman K, Browning R, Coletti A, Mofenson L, Shapiro D, Pilotto J; 1077HS PROMISE Team. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 >/= 400 cells/mm3. PLoS One. 2017 May 10;12(5):e0176009. doi: 10.1371/journal.pone.0176009. eCollection 2017.

  PMID: 28489856 DERIVED

Related Links

• Related Info
• WHO Case Definitions of HIV for Surveillance and Revised Clinical Staging and Immunological Classification of HIV-related Disease in Adults and Children (World Health Organization 2007).

MeSH Terms

Conditions

HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Melissa Allen, Director, IMPAACT Operations Center
• Organization: Family Health International (FHI 360)

mallen@fhi360.org

(919) 405-1429

Study Officials

• Judith S. Currier, MD, MS

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: January 1, 2010
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: August 14, 2023
• Results First Posted: February 19, 2018

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PE (2); HA (1); TH (7); CN (1); AR (1); BO (2); PR (2); BR (8); US (26)