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Antiretroviral Therapy
Early Antiretroviral Therapy for Infant HIV/AIDS (EIT Trial)
Phase 2 & 3
Waitlist Available
Led By Roger L Shapiro, MD, MPH
Research Sponsored by Harvard School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HIV-infection identified by testing conducted within 96 hours after birth NOTE: HIV-infection is defined as DNA PCR positive on at least one specimen, with confirmation specimen either positive or pending**
Age is less than 7 days*
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84-96 weeks
Awards & highlights
EIT Trial Summary
This trial will study whether early ART in HIV-infected infants can help to limit the seeding of viral reservoirs and maintain immune responses.
Who is the study for?
This trial is for newborns in Botswana who were born at or after 35 weeks of gestation, weigh at least 2000 grams, and are HIV-infected within their first week of life. They must be able to start antiretroviral therapy (ART) within seven days after birth and have a guardian able to consent.Check my eligibility
What is being tested?
The study tests if starting ART very early in HIV-infected infants can limit the virus from establishing itself in the body and maintain immune responses. This could potentially allow breaks from treatment in the future.See study design
What are the potential side effects?
Possible side effects from ART drugs like Lamivudine, Zidovudine, Nevirapine, and Kaletra include digestive issues, liver problems, allergic reactions, blood disorders, fatigue, and resistance to medication over time.
EIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My newborn was tested for HIV within 4 days after birth and the result was positive or is still pending.
Select...
I am under 7 days old.
EIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 84-96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84-96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the proportion of infants in the antepartum cohort with trough drug concentrations below defined therapeutic ranges at 7 and 14 days of treatment (trough concentrations will be evaluated for NVP, ZDV, 3TC)
To determine the proportion of infants who fail to achieve at least a 1.5 log10 copies/mL reduction in HIV-1 RNA by the 14th day of treatment
To determine the proportion of infants who have treatment-limiting adverse events within the first 14 days of treatment
+1 moreSecondary outcome measures
Median CD4 cell count (cells/mm3) and 95% confidence intervals among participants
Number of participants with HIV-1 RNA levels <40 copies/mL
Number of participants with reservoir HIV-1 DNA (in copies/million peripheral blood mononuclear cells, PBMCs) below the level of detection for total virus
EIT Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Peripartum CohortExperimental Treatment4 Interventions
10 children who test HIV-negative within 96 hours after birth but test HIV-positive <57 days after birth (peripartum HIV infection) and who are able to initiate ART <57 days after birth. This cohort will include at least 10 children who start ART < 21 days after birth.
The majority of infants in the peripartum cohort will be able to start Kaletra, Zidovudine, Lamivudine as their first regimen, but a minority may start Nevirapine, Zidovudine, Lamivudine and then switch to Kaletra, Zidovudine, Lamivudine.
Group II: Antepartum CohortExperimental Treatment4 Interventions
40 children who test HIV-positive within 96 hours after birth (antepartum HIV infection) and are able to initiate ART < 7 days after birth. This cohort will include at least 15 children who start ART < 3 days after birth.
All infants in the antepartum cohort will initiate ART with Nevirapine, Zidovudine, Lamivudine, and later switch to Kaletra, Zidovudine, Lamivudine.
Group III: Control CohortActive Control1 Intervention
25 HIV-infected children who initiated ART at later age ranges (30-365 days for antepartum infection, 57-365 days for peripartum infection or for those with unknown timing of infection) will be enrolled for a single visit that will occur between 24 and 36 months of age. These children will serve as a control group for virologic and immunologic comparisons with children in the prospective cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritonavir
FDA approved
Lamivudine
FDA approved
Zidovudine
FDA approved
Nevirapine
FDA approved
Find a Location
Who is running the clinical trial?
Harvard School of Public HealthLead Sponsor
122 Previous Clinical Trials
1,935,623 Total Patients Enrolled
Harvard School of Public Health (HSPH)Lead Sponsor
272 Previous Clinical Trials
16,304,945 Total Patients Enrolled
Ragon Institute of MGH, MIT and HarvardOTHER
8 Previous Clinical Trials
1,599 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were born after 35 weeks of pregnancy.You weighed at least 2000 grams at birth.I can start antiretroviral therapy within 7 days after giving birth.I am over 18 and can give my consent.My newborn was tested for HIV within 4 days after birth and the result was positive or is still pending.Your blood will be collected and tested for safety reasons before you can participate in the study.My infant is less than 3 days old at the time of enrollment.You need to be able to visit the clinic for up to 240 weeks after enrolling in the study.You qualify for the Botswana government program that provides antiretroviral therapy (ART).I am under 7 days old.
Research Study Groups:
This trial has the following groups:- Group 1: Control Cohort
- Group 2: Antepartum Cohort
- Group 3: Peripartum Cohort
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to enroll in this research project?
"The clinical trial in question is not recruiting patients at this time, as evidenced by the data on clinicaltrials.gov. This study was first posted on May 4th, 2015 and was last updated on October 17th, 2022. However, there are 295 other trials that are still looking for volunteers."
Answered by AI
How can I get involved in this research project?
"HIV positive individuals who are less than 3 days old may qualify for this clinical trial, which is currently looking to enroll 67 people."
Answered by AI
What are the usual indications for Kaletra?
"Kaletra has many potential applications, including the treatment of human immunodeficiency virus type 1 (hiv-1) infection, hiv, antiretroviral treatment, and sars-cov-2 positive patients."
Answered by AI
Does this research allow for test subjects that are over 35 years old?
"To be eligible for this research study, applicants must be between 0 days and 3 years old. There are a total of 69 studies involving children and 221 with elderly patients."
Answered by AI
How many individuals are enrolled in this clinical study?
"This study is not currently enrolling patients. The listing was created on May 4th, 2015 and edited October 17th, 2022. As of now, there are 244 other trials related to HIV that are active and seeking participants. 51 of these studies focus specifically on Kaletra."
Answered by AI
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