Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1
|First Received Date ICMJE||October 10, 2006|
|Last Updated Date||May 1, 2008|
|Start Date ICMJE||June 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Definitive HIV infection in children as assessed by positive PCR on two peripheral blood samples collected at two separate occasions.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00386230 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Safety: clinical and biological assessment.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1|
|Official Title ICMJE||Short ZDV Course to Prevent Perinatal HIV in Thailand|
The purpose of the study was to test the equivalence of a short zidovudine (ZDV) regimen as compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child transmission of HIV: and to assess and compare the safety and tolerance of the long and shortened ZDV regimens.
Multicenter, randomized, four arms, double-blind, controlled study. Consenting pregnant women were tested for HIV from the beginning of pregnancy until 26 of gestational age (GA). If HIV-positive and eligible, women completed a Pre-entry baseline check-up. Enrollment took place at 28 weeks' gestational age. Women meeting selection criteria were randomly assigned to one of four study arms (see below).
AMENDMENT (March 20, 1999)
Data Safety and Monitory Board interim review (March 17, 1999) The DSMB reported that the transmission rate in the longest arm (long treatment of both mother and baby), was significantly lower than that in the shortest arm (short treatment of both the mother and the baby) and this discrepancy was larger than the previously agreed on difference which, if found, would call for changing the study design. In addition, the transmission rates in the remaining two arms of the study were similar to that in the longest arm. The difference that was found could not be explained by any baseline characteristics of the participants, such as maternal age, gestational age at delivery, birth weight, cesarean section rate, or any others.
The DSMB recommended that enrollment into the shortest arm of the study be terminated, and the study be continued with a modification of design so that new enrollees would enter one of the three remaining arms.
All women enrolled before this amendment was effective and delivering after March 20th, 1999, and previously randomized to the Smother-Sinfant arm, were unblinded in order to give their infants open label zidovudine for 6 weeks.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2000|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Women are eligible for Pre-Entry if they:
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Thailand|
|Removed Location Countries|
|NCT Number ICMJE||NCT00386230|
|Other Study ID Numbers ICMJE||PHPT-1, NIH 5 R01 HD33326-05|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Institut de Recherche pour le Developpement|
|Information Provided By||Institut de Recherche pour le Developpement|
|Verification Date||May 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP