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A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants

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ClinicalTrials.gov Identifier: NCT00000944
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 2, 2012
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date May 2, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
Official Title  ICMJE A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Indinavir Co-Administered With Lamivudine (3TC) and Zidovudine (ZDV) in HIV-1-Infected Pregnant Women During Gestation and Post Partum, and in Their Infants Post Maternal Dosing
Brief Summary

The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in reducing the chances of passing HIV from mother to child. This study will also examine if this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC plus ZDV is safe for newborns.

Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs in this study may be more effective than ZDV alone.

Detailed Description

Despite the dramatic reduction of perinatal HIV transmission following the administration of ZDV to mothers and infants, new, more effective strategies are needed. An increasing number of women may require combination antiretroviral therapy for their own disease because they may be resistant to ZDV, may have high viral loads, or may have previously transmitted HIV to an infant while on ZDV monotherapy. The initiation of triple combination therapy, including a protease inhibitor indinavir, during gestation may be the most effective in reducing maternal virus load prior to delivery, thereby potentially benefitting both mother and child.

Women:

Antepartum (until active labor): Indinavir plus 3TC plus ZDV. Intrapartum (active labor until cord clamping): 3TC plus ZDV. Postpartum (after cord clamped to 12 weeks): Indinavir plus 3TC plus ZDV.

Infants:

3TC plus ZDV as soon as oral intake is tolerated (preferably within 12 hours of birth) and continuing for 6 weeks.

[AS PER AMENDMENT 1/27/99: For maternal dosing, one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV. For mothers who receive Combivir during the antepartum period, Combivir is held during labor and delivery, and the separate formulations of ZDV and 3TC are used. Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.]

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Pregnancy
Intervention  ICMJE
  • Drug: Indinavir sulfate
  • Drug: Lamivudine
  • Drug: Zidovudine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Women may be eligible for this study if they:

  • Are HIV-positive.
  • Have been pregnant for 14-28 weeks (are in your 1st or 2nd trimester).
  • Have a normal ultrasound exam when they are screened for the study.
  • Are able to drink 6 glasses of water a day throughout the study.
  • Are at least 13 years old (need consent of parent or guardian if under 18).

Exclusion Criteria

Women will not be eligible for this study if they:

  • Cannot take 3TC or ZDV.
  • Have an active opportunistic (HIV-associated) or bacterial infection at study entry.
  • Have chronic diarrhea.
  • Have epilepsy or cancer.
  • Are pregnant with more than 2 children (triplets, etc.)
  • Have risk factors for premature birth, or other problems with their pregnancy.
  • Have any immediate life-threatening illness.
  • Have severe anemia or other illness for which they require blood products.
  • Have a history of chronic liver or kidney disease.
  • Plan to breast-feed.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00000944
Other Study ID Numbers  ICMJE ACTG 358
PACTG 358
10606 ( Registry Identifier: DAIDS ES Registry Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Chair: Diana Wara
Study Chair: Yvonne Bryson
Study Chair: Ruth Tuomala
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP