Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Mothers:

• Mothers who have either a presumed or confirmed HIV-positive test result taken around the time of giving birth (presumed results must be confirmed within 10 business days of joining the trial)
• Mothers who are willing and able to sign a consent form for both themselves and their baby, or where a legal guardian provides consent and the mother provides written agreement
• Mothers who have not previously joined this same study with a different baby
• Mothers who did not take any HIV medications during the current pregnancy
• Mothers whose baby also meets the baby eligibility criteria

Babies (to enter the first part of the trial — Step 1):

• Babies who are 48 hours old or younger at the time of joining
• Babies born at 37 weeks of pregnancy or later
• Babies who weighed at least 2 kilograms (about 4.4 pounds) at birth
• Babies who are able to take HIV medications by mouth, feeding tube through the nose, or feeding tube into the stomach
• Babies who do not have any significant health conditions (other than HIV) that, in the site doctor's opinion, would interfere with taking part in the study

Babies (to move into the second part — Step 2):

• Babies who completed Step 1 and have been confirmed to have been infected with HIV before birth
• Babies who are still able to take HIV medications and have no significant health conditions that would interfere with participation
• Babies whose mother or legal guardian is willing and able to sign a new consent form for Step 2

Babies (to move into the third part — Step 3):

• Babies who completed Step 2 and have reached 96 weeks in that step
• Babies whose HIV virus levels in the blood met specific low or undetectable targets throughout Step 2 (confirm exact thresholds with trial site)
• Babies who, if they were breastfed, have had no breast milk for at least six weeks before certain tests are taken
• Babies who had two consecutive negative HIV antibody tests at least eight weeks apart, and two consecutive tests showing no HIV DNA detected, both taken between weeks 84 and 192 of Step 2
• Babies whose immune cell counts (CD4 levels) are at or above the minimum healthy range for their age during Step 2
• Babies who the site doctor believes will be able to follow the Step 3 schedule of visits and tests
• Babies whose mother or legal guardian is willing and able to sign consent for both Step 3 and Step 4
• Babies who have a final test showing no HIV detected in the blood within 14 days before entering Step 3

Babies (to move into the fourth part — Step 4):

• Babies enrolled in Step 3 who show signs that HIV may have returned or that their health has declined, including detectable HIV in the blood on two tests, high HIV levels with signs of illness, a suspected or confirmed new serious HIV-related condition, or immune cell counts that have fallen below the healthy range for their age (confirm with trial site)
• Babies who the site doctor, in consultation with the trial's medical committee, believes need to restart HIV treatment for any other reason

Who may not be able to join:

• Babies who are older than 48 hours at the time of enrolment into Step 1
• Babies born before 37 weeks of pregnancy
• Babies who weighed less than 2 kilograms at birth
• Babies who are unable to take medications by mouth or feeding tube
• Babies who have significant health conditions (other than HIV) that the site doctor believes would affect their ability to take part
• Mothers who previously joined this same study with a different baby
• Mothers who took any HIV medications during the current pregnancy

Important: Always verify eligibility with the trial site directly before applying.