Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1

NCT00386230 | Completed Phase 3

• 2 other identifiers: PHPT-1NIH 5 R01 HD33326-05
• Study Type: interventional
• Target: 1,554
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Pregnancy

Keywords

transmission; infant; HIV; pregnancy; HIV-1 infection; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

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)

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)

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)

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.

Drug: ZDV Long (mother)-Long (infant): Comparison of zidovudine durations

Interventions

ZDV Short (mother)-Short (infant): Comparison of zidovudine durations DRUG

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)

1

ZDV Short (mother)-Long (infant): Comparison of zidovudine durations DRUG

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)

2

ZDV Long (mother)-Short (infant): Comparison of zidovudine durations DRUG

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)

3

ZDV Long (mother)-Long (infant): Comparison of zidovudine durations DRUG

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)

4

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Harvard School of Public Health (HSPH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Phpt - Ird 174

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Related Publications (2)

• 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.

  PMID: 11018164 RESULT

• Sripan 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. Erratum In: PLoS One. 2015 Jun 26;10(6):e0130917. doi: 10.1371/journal.pone.0130917. PLoS One. 2015 Aug 28;10(8):e0137368. doi: 10.1371/journal.pone.0137368.

  PMID: 25992639 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marc Lallemant, MD

  Institut de Recherche pour le Developpement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: June 1, 1997
• Study Completion: August 1, 2000
• Last Updated: May 2, 2008

Record last verified: 2008-05

Locations

TH (1)