HIV InfectionsPhase 3NCT00386230
Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1
A Phase 3 study testing ZDV Short (mother)-Short (infant): Comparison of zidovudine durations, ZDV Short (mother)-Long (infant): Comparison of zidovudine durations and ZDV Long (mother)-Short (infant): Comparison of zidovudine durations in people with HIV Infections and Pregnancy, run by Institut de Recherche pour le Developpement at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV Infections, Pregnancy
- What is being tested?
- ZDV Short (mother)-Short (infant): Comparison of zidovudine durations, ZDV Short (mother)-Long (infant): Comparison of zidovudine durations and ZDV Long (mother)-Short (infant): Comparison of zidovudine durations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,554 participants
- Where
- 1 siteThailand
- Study dates
- Jun 1997to Aug 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all pre-entry criteria;
- date of enrollment: 28 weeks GA, based on last menstrual period and/or sonogram results;
- the following laboratory values within 21 days prior to randomization:
- hemoglobin > 8.0 g/dL;
- absolute neutrophil count > 750 cells/mm3;
- SGPT < 5 x upper limit of normal;
- serum creatinine < 1.5 mg/dL (women with a serum creatinine > 1.5 mg/dL must have a measured eight-hour urine creatinine clearance > 70 mL/min.);
- agreement not to breastfeed.
Who cannot join
- AIDS according to the Thai Communicable Diseases Control (CDC) classification;
- pre-existing maternal/fetal condition that contraindicates the use of ZDV
- oligohydramnios, unexplained polyhydramnios, fetal hydrops or ascites or other evidence of pre-existing in-utero anemia;
- clinically significant history of intolerance to ZDV treatment resulting in discontinuation of therapy for more than 4 weeks;
- receipt of ZDV during the current pregnancy for any indication, or women who need ZDV for their own health (women are then followed separately);
- receipt of other antiretroviral agents, passive immunotherapy, anti-HIV vaccines, cytolytic agents (usually referred as chemotherapy), radiation therapy, or corticosteroids during this pregnancy except steroids less than 7 (see Zidovudine Investigator's Brochure);
- simultaneous participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- HIV Infections, Pregnancy
- Being tested
- ZDV Short (mother)-Short (infant): Comparison of zidovudine durations, ZDV Short (mother)-Long (infant): Comparison of zidovudine durations, ZDV Long (mother)-Short (infant): Comparison of zidovudine durations, ZDV Long (mother)-Long (infant): Comparison of zidovudine durations
- Keywords
- transmission, infant, HIV, pregnancy, HIV-1 infection, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZDV Short (mother)-Short (infant): Comparison of zidovudine durationsDrug
Maternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Sinfant)
ZDV Short (mother)-Long (infant): Comparison of zidovudine durationsDrug
Maternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Linfant)
ZDV Long (mother)-Short (infant): Comparison of zidovudine durationsDrug
Maternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Sinfant)
ZDV Long (mother)-Long (infant): Comparison of zidovudine durationsDrug
Maternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Linfant)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Maternal ZDV treatment starting at 35 weeks Gestational Age (GA) and continuing through labor and delivery, and three days of infant ZDV treatment starting at birth (Smother-Sinfant) Receives: Drug: ZDV Short (mother)-Short (infant): Comparison of zidovudine durations |
| 2 | Experimental | Maternal ZDV treatment starting at 35 weeks Gestational Age (GA) and continuing through labor and delivery, and six weeks of infant ZDV treatment starting at birth (Smother-Linfant) Receives: Drug: ZDV Short (mother)-Long (infant): Comparison of zidovudine durations |
| 3 | Experimental | Maternal ZDV treatment starting at 28 weeks Gestational Age (GA) and continuing through labor and delivery, and three days of infant ZDV treatment starting at birth (Lmother-Sinfant) Receives: Drug: ZDV Long (mother)-Short (infant): Comparison of zidovudine durations |
| 4 | Active comparator | Maternal ZDV treatment starting at 28 weeks Gestational Age (GA) and continuing through labor and delivery, and six weeks of infant ZDV treatment starting at birth (Lmother-Linfant). This study arm was the reference regimen. Receives: Drug: ZDV Long (mother)-Long (infant): Comparison of zidovudine durations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definitive HIV infection in children as assessed by positive PCR on two peripheral blood samples collected at two separate occasions.
Secondary outcomes (1)
Safety: clinical and biological assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startJun 1997
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,554 participants
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Harvard School of Public Health (HSPH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Marc Lallemant, MD, Principal investigator, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386230
- Sponsor's protocol ID
- PHPT-1
- Other IDs
- NIH 5 R01 HD33326-05
- Status last verified
- May 2008
- First submitted
- 10 Oct 2006
- Last updated
- 2 May 2008
- Results posted
- No
Publications
Lallemant M, Jourdain G, Le Coeur S, Kim S, Koetsawang S, Comeau AM, Phoolcharoen W, Essex M, McIntosh K, Vithayasai V. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators. N Engl J Med. 2000 Oct 5;343(14):982-91. doi: 10.1056/NEJM200010053431401.
PubMed 11018164Sripan P, Le Coeur S, Amzal B, Ingsrisawang L, Traisathit P, Ngo-Giang-Huong N, McIntosh K, Cressey TR, Sangsawang S, Rawangban B, Kanjanavikai P, Treluyer JM, Jourdain G, Lallemant M, Urien S. Modeling of In-Utero and Intra-Partum Transmissions to Evaluate the Efficacy of Interventions for the Prevention of Perinatal HIV. PLoS One. 2015 May 19;10(5):e0126647. doi: 10.1371/journal.pone.0126647. eCollection 2015.
PubMed 25992639
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short ZDV Course to Prevent Perinatal HIV in Thailand
- ClinicalTrials.gov ID
- NCT00386230
- Acronym / sponsor ID
- PHPT-1
- Conditions
- HIV Infections, Pregnancy
- Keywords
- transmission, infant, HIV, pregnancy, HIV-1 infection, HIV Seronegativity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,554 participants
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Harvard School of Public Health (HSPH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 1997
- Study completion
- Aug 2000 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ZDV Short (mother)-Short (infant): Comparison of zidovudine durationsMaternal ZDV treatment starting at 35 weeks Gestational Age (GA) and continuing through labor and delivery, and three days of infant ZDV treatment starting at birth (Smother-Sinfant) |
| 2 | Experimental | Drug: ZDV Short (mother)-Long (infant): Comparison of zidovudine durationsMaternal ZDV treatment starting at 35 weeks Gestational Age (GA) and continuing through labor and delivery, and six weeks of infant ZDV treatment starting at birth (Smother-Linfant) |
| 3 | Experimental | Drug: ZDV Long (mother)-Short (infant): Comparison of zidovudine durationsMaternal ZDV treatment starting at 28 weeks Gestational Age (GA) and continuing through labor and delivery, and three days of infant ZDV treatment starting at birth (Lmother-Sinfant) |
| 4 | Active comparator | Drug: ZDV Long (mother)-Long (infant): Comparison of zidovudine durationsMaternal ZDV treatment starting at 28 weeks Gestational Age (GA) and continuing through labor and delivery, and six weeks of infant ZDV treatment starting at birth (Lmother-Linfant). This study arm was the reference regimen. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- all pre-entry criteria;
- date of enrollment: 28 weeks GA, based on last menstrual period and/or sonogram results;
- the following laboratory values within 21 days prior to randomization:
- hemoglobin > 8.0 g/dL;
- absolute neutrophil count > 750 cells/mm3;
Key exclusion criteria (7 listed)
- AIDS according to the Thai Communicable Diseases Control (CDC) classification;
- pre-existing maternal/fetal condition that contraindicates the use of ZDV
- oligohydramnios, unexplained polyhydramnios, fetal hydrops or ascites or other evidence of pre-existing in-utero anemia;
- clinically significant history of intolerance to ZDV treatment resulting in discontinuation of therapy for more than 4 weeks;
- receipt of ZDV during the current pregnancy for any indication, or women who need ZDV for their own health (women are then followed separately);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZDV Short (mother)-Short (infant): Comparison of zidovudine durationsMaternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Sinfant) | Drug | 1 |
| ZDV Short (mother)-Long (infant): Comparison of zidovudine durationsMaternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Linfant) | Drug | 2 |
| ZDV Long (mother)-Short (infant): Comparison of zidovudine durationsMaternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Sinfant) | Drug | 3 |
| ZDV Long (mother)-Long (infant): Comparison of zidovudine durationsMaternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Linfant) | Drug | 4 |
Primary outcome
Definitive HIV infection in children as assessed by positive PCR on two peripheral blood samples collected at two separate occasions.
1 secondary outcome
Safety: clinical and biological assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2008.
- Results publication: PubMed 11018164Lallemant M, Jourdain G, Le Coeur S, Kim S, Koetsawang S, Comeau AM, Phoolcharoen W, Essex M, McIntosh K, Vithayasai V. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators. N Engl J Med. 2000 Oct 5;343(14):982-91. doi: 10.1056/NEJM200010053431401.
- Derived from this study: PubMed 25992639Sripan P, Le Coeur S, Amzal B, Ingsrisawang L, Traisathit P, Ngo-Giang-Huong N, McIntosh K, Cressey TR, Sangsawang S, Rawangban B, Kanjanavikai P, Treluyer JM, Jourdain G, Lallemant M, Urien S. Modeling of In-Utero and Intra-Partum Transmissions to Evaluate the Efficacy of Interventions for the Prevention of Perinatal HIV. PLoS One. 2015 May 19;10(5):e0126647. doi: 10.1371/journal.pone.0126647. eCollection 2015.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Lallemant, MD principal investigator
Institut de Recherche pour le Developpement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZDV Short (mother)-Short (infant): Comparison of zidovudine durations, ZDV Short (mother)-Long (infant): Comparison of zidovudine durations and ZDV Long (mother)-Short (infant): Comparison of zidovudine durations in people with HIV Infections and Pregnancy, run by Institut de Recherche pour le Developpement at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definitive HIV infection in children as assessed by positive PCR on two peripheral blood samples collected at two separate occasions.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00386230, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2008; AzTrials last refreshed its copy on 8 Nov 2026.