|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by (Responsible Party): | International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00955968 |
Purpose
The purpose of this study is to see if pregnant women receiving highly active antiretroviral treatment (HAART) to prevent mother-to-child transmission of HIV will be healthier if, after delivery, they continue or stop HAART.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Highly active antiretroviral therapy (HAART) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study |
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Continue HAART
Participants will continue receiving HAART after delivery of their babies.
|
Drug: Highly active antiretroviral therapy (HAART)
A standard combination of three or more HIV medications belonging to two or more drug classes
|
|
Active Comparator: Stop HAART
Participants will stop receiving HAART after delivery of their babies.
|
Drug: Highly active antiretroviral therapy (HAART)
A standard combination of three or more HIV medications belonging to two or more drug classes
|
Highly active antiretroviral therapy (HAART) is not recommended immediately for all HIV-infected people, only those who have significant illnesses or a CD4 count below 350. However, in pregnancy, HIV-infected women are recommended to start HAART regardless of their own HIV progression for prevention of mother-to-child transmission (pMTCT) of HIV. Women who begin taking HAART for pMTCT often stop treatment after delivery, but new data in non-pregnant adults indicates that stopping treatment may lead to negative long-term health outcomes. This study will examine whether it is healthier for pregnant, HIV-infected women receiving HAART for pMTCT to continue or stop treatment.
Participation in this study will be of variable length; participants will be recruited over four years, and all participants will continue to be followed until 84 weeks after the last woman is assigned to a study group. Participants will be randomly assigned to one of two groups: one group will stop HAART and the other will continue HAART. Participants assigned to stop HAART will receive instructions from the study staff on how and when to stop taking medications. These participants will be monitored and will start treatment again if their HIV progresses.
The first study visit will take place within 28 days of delivery, and subsequent visits will occur after 4 weeks, 12 weeks, and then every 3 months until the end of the study. During these study visits, participants will complete questionnaires and interviews about medication history, receive a physical exam, and have blood and urine collected for HIV blood tests and pregnancy tests. Participants will also be asked if they are willing to have some of their blood stored to be used in later testing.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
NOTE: Women on a triple nucleoside regimen during pregnancy are eligible but will be switched to a study-provided HAART regimen if randomized to continue HAART (Arm A).
NOTE: This result will be obtained from the participant's medical records, if available.
Exclusion Criteria:
Contacts and Locations
Show 24 Study Locations| Study Chair: | Judith S. Currier, MD, MS | UCLA CARE Center |
More Information
| Responsible Party: | International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00955968 History of Changes |
| Other Study ID Numbers: | IMPAACT 1077HS, U01AI068632 |
| Study First Received: | August 7, 2009 |
| Last Updated: | September 7, 2011 |
| Health Authority: | United States: Federal Government |
|
Perinatal Transmission of HIV HAART HIV Seronegativity |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |