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New treatment option for HIV Infection
Official title Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
ClinicalTrials.gov ID: NCT02140255
What this study is testing
What is Nucleoside Reverse Transcriptase Inhibitors (NRTIs)?
Nucleoside Reverse Transcriptase Inhibitors (NRTIs) is an investigational medicine, being studied as a potential treatment for hiv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 192 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 48
You may be able to join if
- Maternal 1. Presumed or confirmed maternal HIV infection:
- Mothers will be eligible to enroll with EITHER:
- Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period...
- Confirmed HIV infection defined as positive results from two samples collected at different timepoints
- Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to...
See the full eligibility criteria
- Maternal 1. Presumed or confirmed maternal HIV infection:
- Mothers will be eligible to enroll with EITHER:
- Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR
- Confirmed HIV infection defined as positive results from two samples collected at different timepoints
- Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard...
- Was not previously enrolled in this study with another infant.
- Did not receive ARVs during the current pregnancy.
- Infant is eligible per . Infant for Step 1
- Less than or equal to 48 hours of age.
- Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or...
- Greater than or equal to 2 kilograms (kg) at birth.
- Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.
- Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion...
- Mother is eligible per . Infant for Step 2
- Enrolled in Step 1.
- Confirmed in utero HIV infection.
- Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.
- Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion...
- Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2. Infant for Step 3
- Enrolled in Step 2.
- Has reached Step 2 Week 96.
- Has the following results based on testing:
- No confirmed plasma HIV RNA ≥200 copies/mL at Step 2 Week 24 and up to but excluding Step 2 Week 48.
- No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions
- (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \<200 copies/mL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within...
- If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \<200 copies/mL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2...
- If HIV RNA is detected on the confirmatory test with a result ≥200 copies/mL, the infant will not be eligible for Step 3.
- (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \<LOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA...
- Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.
- If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.
- Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):
- Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.
- Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.
- CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells/mL if 2 to less than 3 years of age; ≥750 cells/mL if 3 to less than 5...
- Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.
- Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.
- No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry. Infant for Step 4
- Enrolled in Step 3.
- Has met at least one of the following:
- Plasma HIV RNA ≥LOD based on two assays.
- Plasma HIV RNA ≥1000 copies/mL in the presence of fever or other sign or symptom of acute retroviral syndrome.
- Confirmed or suspected diagnosis of acute retroviral syndrome.
- Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.
- Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\<1000 cells/mL if 2 to less than 3 years of age; \<750 cells/mL if 3 to less than 5 years of age...
- Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Stony Brook, New York, United States
- The Bronx, New York, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Buenos Aires, Argentina
- Porto Alegre, Rio Greande Do Sul, Brazil
- Minas Gerais, Brazil
- Rio de Janeiro, Brazil
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 192 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 48 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Fort Lauderdale, Florida, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.