Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102960
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2005-02-04
Brief Title:
Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Open-Label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly After Primary Infection in a Resource Poor Setting
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth
Detailed Description:
In South Africa an estimated 250000 infants are born to HIV-infected mothers each year A high percentage of perinatal HIV infections are due to inadequate or absent mother-to-child transmission prophylaxis Unfortunately even with optimal prophylaxis relatively large numbers of HIV-infected infants will continue to be born and will require antiretroviral therapy ART Determining the appropriate times for initiating and interrupting treatment to benefit long-term prognosis in infants is a significant health challenge Evidence suggests that starting ART early during acute infection will provide long-term benefits However longer duration of treatment increases the chance of developing drug-resistant virus and continuous therapy begun early leads to long-term complications in children This study will evaluate the efficacy of two different short-course ART strategies in HIV-infected infants from South Africa
This study will last at least 35 years There are two parts to this study In Part A infants with a baseline CD4 percentage CD4 of at least 25 and HIV infection diagnosed between 6 and 12 weeks of age will be randomly assigned to one of two treatment strategy arms Arm 2 infants will receive ART for approximately 40 weeks until their first birthday Arm 3 infants will receive ART for approximately 96 weeks until their second birthday Treatment in both arms of Part A will begin with first-line continuous treatment of zidovudine lamivudine and lopinavirritonavir Those who were initially deferred treatment in Arm 1 will be reassessed for initiation of first-line continuous ART
First-line ART will be started in Arm 1 or restarted after interruption in Arms 2 and 3 if the appropriate criteria as defined in the protocol is met First-line treatment of zidovudine lamivudine and lopinavirritonavir will continue until infants reach a study endpoint when this occurs infants will then change to second-line therapy Second-line ART will consist of didanosine abacavir sulfate nevirapine and efavirenz
All the primary efficacy analysis for this study will focus on the children enrolled in the first phase of Part A n377 as proposed by the data safety and monitoring board
Follow-up visits will take place for 35 to 5 years depending on time of enrollment All infants will receive routine immunizations and cotrimoxazole sulfamethoxazoletrimethoprim prophylaxis from age 6 weeks until Week 40 Study visits will occur at study entry Weeks 2 4 8 12 16 20 24 32 40 and 48 and every 12 weeks thereafter At these visits infants will have vital sign measurements a physical exam and a medical history evaluation Blood and urine collection will occur at all study visits Infants parents or guardians will also be asked to complete an adherence questionnaire
Participants enrolled in CIPRA-ZA Project 2 are encouraged to enroll in an observational substudy organized by the Wistar Institute Dr Luis Montaner Principal Investigator in conjunction with the CIPRA team This study is entitledPediatric Immune Correlates of Early Anti-HIV Therapy The goal of this 5-year substudy is to evaluate 120 HIV infected children from the parent study twice a year and compare them to HIV uninfected age-matched controls Children will be evaluated by a characterization and identification of the innate and adaptive immune reconstitution outcomes of early 9 or 21 months therapy in infants infected with HIV at birth and b identification of immune correlate outcomes to clinical progression within a period of 2 to 3 years of follow-up after stopping therapy
This study will last at least 35 years There are two parts to this study In Part A infants with a baseline CD4 percentage CD4 of at least 25 and HIV infection diagnosed between 6 and 12 weeks of age will be randomly assigned to one of two treatment strategy arms Arm 2 infants will receive ART for approximately 40 weeks until their first birthday Arm 3 infants will receive ART for approximately 96 weeks until their second birthday Treatment in both arms of Part A will begin with first-line continuous treatment of zidovudine lamivudine and lopinavirritonavir Those who were initially deferred treatment in Arm 1 will be reassessed for initiation of first-line continuous ART
First-line ART will be started in Arm 1 or restarted after interruption in Arms 2 and 3 if the appropriate criteria as defined in the protocol is met First-line treatment of zidovudine lamivudine and lopinavirritonavir will continue until infants reach a study endpoint when this occurs infants will then change to second-line therapy Second-line ART will consist of didanosine abacavir sulfate nevirapine and efavirenz
All the primary efficacy analysis for this study will focus on the children enrolled in the first phase of Part A n377 as proposed by the data safety and monitoring board
Follow-up visits will take place for 35 to 5 years depending on time of enrollment All infants will receive routine immunizations and cotrimoxazole sulfamethoxazoletrimethoprim prophylaxis from age 6 weeks until Week 40 Study visits will occur at study entry Weeks 2 4 8 12 16 20 24 32 40 and 48 and every 12 weeks thereafter At these visits infants will have vital sign measurements a physical exam and a medical history evaluation Blood and urine collection will occur at all study visits Infants parents or guardians will also be asked to complete an adherence questionnaire
Participants enrolled in CIPRA-ZA Project 2 are encouraged to enroll in an observational substudy organized by the Wistar Institute Dr Luis Montaner Principal Investigator in conjunction with the CIPRA team This study is entitledPediatric Immune Correlates of Early Anti-HIV Therapy The goal of this 5-year substudy is to evaluate 120 HIV infected children from the parent study twice a year and compare them to HIV uninfected age-matched controls Children will be evaluated by a characterization and identification of the innate and adaptive immune reconstitution outcomes of early 9 or 21 months therapy in infants infected with HIV at birth and b identification of immune correlate outcomes to clinical progression within a period of 2 to 3 years of follow-up after stopping therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIPRA-SA Project 2 | OTHER | CIPRA | httpsreporternihgovquickSearch5R01AI062512-02 |
| 10404 | REGISTRY | None | None |
| CHER | REGISTRY | None | None |
| 5R01AI062512-02 | NIH | None | None |