Option B+: Study on Safety, Viral Suppression, and Survival on Second Line ART

NCT02249962 | Completed DMC

• 2 other identifiers: 14-1633R01HD080485
• Study Type: observational
• Target: 12,011
• Locations: 1 country
• Sites: 1

Brief Summary

To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.

Conditions

HIV; Infant Exposure to Efavirenz

Keywords

prospective; cohort

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with failure on Option B+ first-line treatment

  Proportion of women who fail first-line treatment as indicated by one or more of the following criteria: WHO Stage 3 or 4 events (as defined by Appendix 60 of the Adult AIDS Clinical Trials Group (AACTG)), or DAIDS grade 3 or 4 toxicity (lab serum markers), or proportion with treatment discontinuation (or death), or proportion with virologic failure (as measured by HIV RNA levels)

  Up to 36 months

Secondary Outcomes (11)

• Pharmacokinetic: progesterone level in women using contraceptive implant

  months 3, 6, 12, 24

• Micronutrient assessment

  Baseline, months 6, 12, 24, 36

• Maternal CD4 count

  baseline, months 12, 24, 36 post-ART initiation

• HIV RNA level measurement

  baseline, months 3, 6, 12, 24, 36

• PHQ-9 evaluation

  baseline, months 6, 12, 18, 24, 30, 36

Study Arms (4)

Overall cohort: HIV+ women on Option B+ and their infants

Women (n=8000) visiting an antenatal clinic for care who will be followed prospectively for Malawi standard treatment outcomes and pregnancy outcomes as patients on Option B+

Sub-cohort A: first HIV diagnosis

Women (n=300) who present to the antenatal care clinic and are diagnosed for the first time with HIV. These women will be started on Option B+ as anti-retroviral treatment, per Malawi Ministry of Health standard of care.

Sub-cohort B: subsequent pregnancies failing 1st line ART

Women (n=150) who have failed first-line treatment (TDF/3TC/EFV) based on HIV RNA levels and CD4 count. These women will be switched to second-line treatment (AZT/3TC/ATZ/r) per Malawi Ministry of Health standard of care.

Sub-cohort C: subsequent pregnancies who default from 1st line

Women (n=150) who are HIV+ and have a subsequent pregnancy who have not been adherent to first-line (Option B+: TDF/3TC/EFV). These women will be re-initiated on first-line treatment for 3 months, then evaluated to assess whether continuation on first-line treatment is sufficient, or if they need to be switched to second-line treatment (AZT/3TC/ATZ/r) per Malawi Ministry of Health standard of care.

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV+ pregnant women and their infants recruited from three clinic sites in Lilongwe, Malawi.

You may qualify if:

• Female age ≥16 (includes adults and emancipated minors)
• HIV positive by 2 rapid tests approved by the Malawi Ministry of Health
• Willingness to provide informed consent

You may not qualify if:

• Female \<16 years
• HIV negative
• Incapable of providing informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Ministry of Health and Population, Malawi: collaborator
• University of North Carolina: collaborator
• Lighthouse Trust: collaborator
• Baylor College of Medicine: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

UNC Project Malawi

Lilongwe, Malawi

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum samples for: * HIV genotyping * micronutrient status * pharmacokinetics: efavirenz and progesterone levels for women using the contraceptive implant only

Study Officials

• Mina C Hosseinipour, MD, MPH

  UNC Project- Malawi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 26, 2014
• Study Start: May 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 12, 2021

Record last verified: 2020-05

Locations

MA (1)