Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy

NCT00017719 | Completed Phase 3

• 4 other identifiers: P102210192ACTG P1022PACTG P1022
• Study Type: interventional
• Target: 440
• Locations: 4 countries
• Sites: 49

Brief Summary

The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors (PIs) are often used, but they have side effects that may be harmful for pregnant women. It is not known if treatment regimens that do not include PIs are as effective in pregnant women as those that include PIs. This trial will compare two anti-HIV treatment plans, one with and one without PIs, in women who start HIV treatment during pregnancy. The study will evaluate the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child HIV transmission during pregnancy.

Conditions

HIV Infections; Pregnancy

Keywords

Pregnancy Complications, Infectious; HIV Protease Inhibitors; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; Combivir; Treatment Naive

Outcome Measures

Primary Outcomes (2)

• Proportion of women in each treatment group who continue on original therapy with virologic suppression to less than 500 copies/ml at 34 weeks gestation (or the last viral load determination prior to delivery)

• proportion of women in each treatment group who continue on original therapy with virologic suppression to less than 500 copies/ml at 48 weeks postpartum

Secondary Outcomes (11)

• Proportion of women in each treatment group who continue on original therapy with virologic suppression to less than 50 copies/ml at 34 weeks gestation (or the last viral load determination prior to delivery)

• proportion of women in each treatment group who continue on original therapy with virologic suppression to less than 50 copies/ml at 48 weeks postpartum, and to less than 500 and 50 copies/ml at 104 weeks postpartum

• study treatment adherence and health status by self-report, correlated with predose nelfinavir or nevirapine level at 34 weeks gestation and 8 weeks postpartum

• difference between postpartum and pregnancy 12-hour area under the concentration curve (AUC) for nevirapine

• time of trough levels in relation to the morning dose of nevirapine and nelfinavir at 34 weeks gestation and 8 weeks postpartum and correlation of trough levels with viral load

Interventions

Lamivudine DRUG

Lamivudine/Zidovudine DRUG

Nelfinavir mesylate DRUG

Nevirapine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• to 30 weeks pregnant
• Plan to continue pregnancy
• CD4 count less than 250 cells/mm3 within 30 days of study entry
• HIV RNA load greater than 1,000 copies/ml within 30 days of study entry
• Antiretroviral naive (except ZDV for 8 weeks or less, including prior pregnancy)
• Willing to follow study requirements and plan to continue receiving anti-HIV treatment for at least 2 years after delivery
• Understand that NFV will not be supplied by the study (except for the first 12 women in Group A)
• Understand the study drug NVP will not be supplied after 1 year following delivery and is reasonably certain that she can obtain NVP by prescription for the second year of the study
• Access to a participating site
• Willing to have infant followed until 24 weeks old
• Parent or guardian willing to provide informed consent, if applicable

You may not qualify if:

• Alcohol or drug abuse
• Chemotherapy for an active cancer
• Require certain medications
• AIDS-related opportunistic infection and/or serious bacterial infection or unstable or serious medical condition within 14 days of study entry
• Chronic malabsorption or diarrhea
• Diabetes, unless it only occurs during pregnancy
• Major fetal problem or abnormality
• Abnormal amniotic fluid volume
• Plan to breastfeed
• Acute hepatitis within 90 days of study entry
• Skin problems such as psoriasis or eczema that require systemic treatment
• Any serious disease that, in the opinion of the study official, would compromise study participation

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (49)

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

UCSD Mother-Child-Adolescent Program CRS

San Diego, California, 92103, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, United States

Location

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, 90509, United States

Location

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, 06504, United States

Location

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp.

Miami, Florida, 33136, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Augusta, Georgia, 30912, United States

Location

Columbus Regional HealthCare System, The Med. Ctr.

Columbus, Georgia, 31901, United States

Location

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

Chicago, Illinois, 60608, United States

Location

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, 60637-1470, United States

Location

Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic

New Orleans, Louisiana, 70112-2699, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112-2699, United States

Location

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, 21287-4933, United States

Location

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 02115, United States

Location

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, 02118, United States

Location

Brigham and Women's Hosp., Div. of Infectious Disease

Boston, Massachusetts, 02478, United States

Location

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, 01199, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, 01655, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

Univ. of Mississippi Med. Ctr Children's Hosp.

Jackson, Michigan, 39213, United States

Location

Rutgers - New Jersey Medical School CRS

Newark, New Jersey, 07103, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Strong Memorial Hospital Rochester NY NICHD CRS

Rochester, New York, 14642, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

Montefiore Med. Ctr. - AECOM

The Bronx, New York, 19461, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109-1998, United States

Location

Oregon Health & Science Univ. - Dept. of Peds., Div. of Infectious Disease

Portland, Oregon, United States

Location

Regional Med. Ctr. at Memphis

Memphis, Tennessee, 38105, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105, United States

Location

Vanderbilt Univ. Med. Ctr., Div. of Ped. Infectious Diseases

Nashville, Tennessee, 38105, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

Univ. of Washington NICHD CRS

Seattle, Washington, 98105-0371, United States

Location

UW Medicine - Harborview Med. Ctr., Northwest Family Ctr.

Seattle, Washington, 98105-0371, United States

Location

UW School of Medicine - CHRMC

Seattle, Washington, 98105-0371, United States

Location

Seattle Children's Hospital CRS

Seattle, Washington, United States

Location

SOM Federal University Minas Gerais Brazil NICHD CRS

Belo Horizonte, Minas Gerais, Brazil

Location

Hosp. dos Servidores Rio de Janeiro NICHD CRS

Rio de Janeiro, 20221-903, Brazil

Location

Hosp. dos Servidores do Estado CRS

Rio de Janeiro, 22261-161, Brazil

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Princess Margaret Hosp. Bahamas NICHD CRS

Nassau, The Bahamas

Location

Related Publications (4)

• Loutfy MR, Walmsley SL. Treatment of HIV infection in pregnant women: antiretroviral management options. Drugs. 2004;64(5):471-88. doi: 10.2165/00003495-200464050-00002.

  PMID: 14977385 BACKGROUND

• Moodley J, Moodley D. Management of human immunodeficiency virus infection in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2005 Apr;19(2):169-83. doi: 10.1016/j.bpobgyn.2004.10.007. Epub 2004 Dec 15.

  PMID: 15778108 BACKGROUND

• Hitti J, Frenkel LM, Stek AM, Nachman SA, Baker D, Gonzalez-Garcia A, Provisor A, Thorpe EM, Paul ME, Foca M, Gandia J, Huang S, Wei LJ, Stevens LM, Watts DH, McNamara J; PACTG 1022 Study Team. Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):772-6. doi: 10.1097/00126334-200407010-00002.

  PMID: 15213559 RESULT

• Capparelli EV, Aweeka F, Hitti J, Stek A, Hu C, Burchett SK, Best B, Smith E, Read JS, Watts H, Nachman S, Thorpe EM Jr, Spector SA, Jimenez E, Shearer WT, Foca M, Mirochnick M; PACTG 1026S Study Team; PACTG P1022 Study Team. Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008 Apr;9(4):214-20. doi: 10.1111/j.1468-1293.2008.00553.x.

  PMID: 18366444 RESULT

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

Lamivudine; lamivudine, zidovudine drug combination; Nelfinavir; Nevirapine; Zidovudine

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; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Thymidine

Study Officials

• Jane Hitti, MD, MPH

  Department of Obstetrics/Gynecology, University of Washington Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2001
• First Posted: August 31, 2001
• Study Start: May 1, 2002
• Study Completion: March 1, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

TH (1); BR (3); US (44); PR (1)