Phase 4
N=1,653
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00955968 ↗Enrolled (actual)
1,653
Serious AEs
0.8%
Results posted
Feb 2018
Primary outcome: Primary: Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death — 0.21; 0.31 New cases per 100 person - years — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Highly active antiretroviral therapy (HAART) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death |
0.21; 0.31 | 0.54 |
| SECONDARY Incidence Rate of AIDS - Defining Illness |
0.10; 0.15 | 0.66 |
| SECONDARY Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event |
0; 0 | — |
| SECONDARY Incidence Rate of Deaths |
0.10; 0.20 | 0.44 |
| SECONDARY Incidence Rate of HIV/AIDS Related Events |
1.32; 1.42 | 0.79 |
| SECONDARY Incidence Rate of HIV/AIDS Related Events or Death |
1.42; 1.57 | 0.71 |
| SECONDARY Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events |
3.09; 5.37 | <0.001 sig |
| SECONDARY Incidence Rate of Grade 2 and Above Toxicity |
18.4; 15.6 | 0.10 |
| SECONDARY Incidence Rate of Cardiovascular or Other Metabolic Events |
— | — |
| SECONDARY Incidence Rate of Other Targeted Medical Conditions |
— | — |
| SECONDARY Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death |
— | — |
| SECONDARY Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm |
19 | — |
| SECONDARY Medication Adherence - Last Time Missed Medications |
489; 60; 123; 411; 97; 144 | — |
| SECONDARY Medication Adherence - How Closely Followed Schedule |
23; 130; 520; 17; 173; 461 | — |
| SECONDARY Medication Adherence - How Often Follow Instructions |
10; 52; 166; 439; 6; 61 | — |
| SECONDARY Medication Adherence - Missed Dose Within Past 4 Days |
592; 61; 564; 71; 544; 77 | — |
| SECONDARY Quality of Life - General Health Outcome |
160; 164; 262; 269; 327; 333 | — |
| SECONDARY Quality of Life (QoL) - Health Rating Score |
82.7; 83.0; 85.3; 85.4; 86.2; 86.3 | — |
| SECONDARY Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers |
— | — |
| SECONDARY Cost Effectiveness and Feasibility of Treatment Models |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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)
Data sourced from ClinicalTrials.gov (NCT00955968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.