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HIV InfectionsPhase 3NCT00017719

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

A Phase 3 study testing Lamivudine, Lamivudine/Zidovudine and Nelfinavir mesylate in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 49 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 14 years and older, women only
Conditions the study is for
HIV Infections, Pregnancy
What is being tested?
Lamivudine, Lamivudine/Zidovudine and Nelfinavir mesylate
How many people
440 participants
Where
49 sitesin 4 countries
Study dates
May 2002to Mar 2006
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 14 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • HIV infected
  • 10 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

49 sites in 4 countries.

49 sites in 4 countries

United States44 sites

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

    Augusta, Georgia, 30912

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

    Baltimore, Maryland, 21287-4933

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

    Baltimore, Maryland

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

    Boston, Massachusetts, 02115

  • BMC, Div. of Ped Infectious Diseases

    Boston, Massachusetts, 02118

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

    Boston, Massachusetts, 02478

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

    Chicago, Illinois, 60608

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

    Chicago, Illinois, 60637-1470

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio, 45267

  • Case CRS

    Cleveland, Ohio, 44106

  • MetroHealth CRS

    Cleveland, Ohio, 44109-1998

  • Columbus Regional HealthCare System, The Med. Ctr.

    Columbus, Georgia, 31901

  • Children's Hospital of Michigan NICHD CRS

    Detroit, Michigan, 48201

  • DUMC Ped. CRS

    Durham, North Carolina, 27710

  • Texas Children's Hosp. CRS

    Houston, Texas, 77030

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

    Jackson, Michigan, 39213

  • Usc La Nichd Crs

    Los Angeles, California, 90033

  • Regional Med. Ctr. at Memphis

    Memphis, Tennessee, 38105

  • St. Jude/UTHSC CRS

    Memphis, Tennessee, 38105

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

    Miami, Florida, 33136

  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS

    Miami, Florida, 33161

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

    Nashville, Tennessee, 38105

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

    New Haven, Connecticut, 06504

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

    New Orleans, Louisiana, 70112-2699

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana, 70112-2699

  • Nyu Ny Nichd Crs

    New York, New York, 10016

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Rutgers - New Jersey Medical School CRS

    Newark, New Jersey, 07103

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

    Portland, Oregon

  • Strong Memorial Hospital Rochester NY NICHD CRS

    Rochester, New York, 14642

  • UCSD Mother-Child-Adolescent Program CRS

    San Diego, California, 92103

  • UCSF Pediatric AIDS CRS

    San Francisco, California

  • Univ. of Washington NICHD CRS

    Seattle, Washington, 98105-0371

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

    Seattle, Washington, 98105-0371

  • UW School of Medicine - CHRMC

    Seattle, Washington, 98105-0371

  • Seattle Children's Hospital CRS

    Seattle, Washington

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 11794

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

    Syracuse, New York, 13210

  • Bronx-Lebanon Hosp. IMPAACT CRS

    The Bronx, New York, 10457

  • Montefiore Med. Ctr. - AECOM

    The Bronx, New York, 19461

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

    Torrance, California, 90509

  • Howard Univ. Washington DC NICHD CRS

    Washington D.C., District of Columbia, 20060

  • WNE Maternal Pediatric Adolescent AIDS CRS

    Worcester, Massachusetts, 01655

Other trials in United States

Brazil3 sites

  • SOM Federal University Minas Gerais Brazil NICHD CRS

    Belo Horizonte, Minas Gerais

  • Hosp. dos Servidores Rio de Janeiro NICHD CRS

    Rio de Janeiro, 20221-903

  • Hosp. dos Servidores do Estado CRS

    Rio de Janeiro, 22261-161

Other trials in Brazil

Puerto Rico1 site

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 00936

Other trials in Puerto Rico

The Bahamas1 site

  • Princess Margaret Hosp. Bahamas NICHD CRS

    Nassau

About this study

Official title: Randomized Trial of Protease Inhibitor-Including vs. Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy

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.

Read the detailed description

The optimal treatment strategy for women who initiate antiretroviral therapy during pregnancy is not known. Although PI-based antiretroviral regimens are prescribed with increasing frequency among pregnant women, the efficacy and safety of this approach is unknown. Pregnant women are at increased risk for glucose intolerance and insulin resistance; PIs are associated with glucose intolerance. Physiologic differences between pregnant women and nonpregnant adults may alter the pharmacokinetics of antiretroviral regimens. Fetal safety considerations and effects on perinatal HIV transmission must also be considered when selecting an antiretroviral regimen for pregnant women. This trial will compare PI-based and PI-sparing antiretroviral regimens for women initiating antiretroviral therapy in pregnancy.

Women will be stratified on the basis of viral load (50,000 or less copies/ml or greater than 50,000 copies/ml) and gestational age at entry (20 or less weeks or greater than 20 weeks) and then randomized to one of two treatment groups. Group A will receive the PI nelfinavir (NFV) with zidovudine (ZDV) and lamivudine (d4T); Group B will receive nevirapine (NVP) with ZDV and d4T. Women will have clinic visits for physical and obstetrical examinations at 2, 4, 6, and 8 weeks after entry and then every 4 weeks until delivery. After delivery, infants in both groups may receive ZDV until they are 6 weeks old. Infants are evaluated for safety and to test the infant's blood for HIV-1 at birth and at Weeks 2, 8, 16, and 24.

Women will continue on assigned antiretroviral therapy postpartum and will have 11 postpartum clinic visits over a period of 2 years. Blood samples from women will be evaluated for safety and for virologic, pharmacokinetic, and metabolic studies. The first 12 women randomized to Group A will undergo a 4-hour pharmacokinetic profile at 32 to 36 weeks gestation and at 8 weeks postpartum to determine the timing of the nelfinavir trough. The first 20 women randomized to Group B will undergo an 8-hour pharmacokinetic profile at either 16 to 24 weeks or 32 to 36 weeks gestation and then again at 8 weeks postpartum to characterize pharmacokinetics of nevirapine at steady state in pregnancy and in the postpartum period.

Being tested
Lamivudine, Lamivudine/Zidovudine, Nelfinavir mesylate, Nevirapine, Zidovudine
Keywords
Pregnancy Complications, Infectious, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Combivir, Treatment Naive
Medical subject headings
HIV Infections, Pregnancy Complications, Infectious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  2. 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)

  1. 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)

  2. 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

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

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

  5. 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

  6. incidence of HIV viral resistance by genotype among women in each treatment group at the time of virologic failure

  7. incidence of abnormal glucose tolerance, gestational diabetes, and abnormal lactate levels during pregnancy in each treatment group

  8. incidence of impaired glucose tolerance, diabetes, hyperinsulinemia, and elevated cholesterol and triglycerides at 8 weeks postpartum in each treatment group

  9. incidence of anemia, hypoglycemia, and abnormal liver function studies among infants born to women in each treatment group

  10. incidence of prematurity (less than 37 weeks), extreme prematurity (less than 32 weeks), low birth weight (less than 2.5 kg), and very low birth weight (less than 1.5 kg) among infants born to women in each treatment group

  11. perinatal HIV transmission among infants born to women in each treatment group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study startMay 2002
  3. Study completionMar 2006

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
440 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017719
Sponsor's protocol ID
P1022
Other IDs
10192, ACTG P1022, PACTG P1022
Status last verified
Oct 2021
First submitted
8 Jun 2001
Last updated
1 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 14977385

  • 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.

    PubMed 15778108

  • 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.

    PubMed 15213559

  • 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.

    PubMed 18366444

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lamivudine, Lamivudine/Zidovudine and Nelfinavir mesylate in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 49 sites in 4 countries.

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 12 inclusion and 12 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Brazil, Puerto Rico, The Bahamas. 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?

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). The study lists 2 primary outcomes in all. 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 NCT00017719, which also lists 4 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 1 Nov 2021.

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