Featured Research

from universities, journals, and other organizations

Study Shows Efavirenz Promising In Treating Pediatric HIV Infection: Leads To Approval Of New Drug For Treating HIV-Infected Children

Date:
October 1, 1998
Source:
National Institute Of Allergy And Infectious Diseases
Summary:
Investigators have announced results of an interim analysis of the first pediatric study of efavirenz, a new non-nucleoside reverse transcriptase inhibitor that when used in combination with nelfinavir and other antiretrovirals, suppressed HIV replication over a 20-week period in most children.

Investigators of the Pediatric AIDS Clinical Trials Group (PACTG), a network of trial sites supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD), have announced results of an interim analysis of the first pediatric study of efavirenz, a new non-nucleoside reverse transcriptase inhibitor (NNRTI) that can be taken once daily. The purpose of the study, known as PACTG 382, is to determine the safety, dosing and antiviral effect of efavirenz in combination with antiretrovirals in HIV-infected children. Efavirenz, when used in combination with nelfinavir and other antiretrovirals, suppressed HIV replication over a 20-week period in most children.

"This study demonstrates that efavirenz used in combination with other antiretrovirals can have potent antiviral effects in children," comments Anthony S. Fauci, M.D., NIAID director. "It offers another choice for treating HIV-infected children who currently have fewer treatment options than adults." At present, 12 drugs are approved for treating HIV disease in adults, compared to seven, including efavirenz, approved for children. Efavirenz is the second drug in the NNRTI class of antivirals to be approved for use in children.

The study directly contributed to accelerated Food and Drug Administration approval earlier this month of efavirenz as a treatment option for HIV-infected children. Study Chair Stuart Starr, M.D., of the Children's Hospital of Philadelphia, says, "Timely collaboration between PACTG investigators and pharmaceutical companies made it possible for efavirenz to be approved for HIV-infected children at the same time that it was approved for adults."

PACTG 382 is a Phase I/II multicentered study evaluating a combination therapy consisting of efavirenz, the protease inhibitor nelfinavir and nucleoside reverse transcriptase inhibitors (NRTIs). As a safeguard, this highly intensive study was designed to closely monitor blood levels of efavirenz and nelfinavir. Drug doses were adjusted as needed.

A total of 57 children were enrolled in the study. Participants were younger than 16 years, had not been previously treated with protease inhibitors or NNRTIs, and were able to swallow capsules. The median age of the children was 8.0 years; the median CD4+ T cell count was 699 cells/mm3, and the median viral load was 10,000 copies HIV RNA/ml. NRTIs were continued or changed at entry as clinically indicated. Pharmacokinetic studies were carried out at weeks two and six. Efavirenz was given at a starting dose of 600 mg/m2 once a day in combination with nelfinavir at the currently approved dose of 20-30 mg/kg three times per day. To date, this combination has been well tolerated by most subjects.

The most common side effects were: rash (28.1 percent), which was seen more commonly in children than in adults; diarrhea (15.8 percent); and abnormally low levels of neutrophils (8.8 percent), a type of white blood cell. The percentage of participants whose HIV RNA was less than 400 copies/ml was 3.5 percent at baseline, 51.9 percent at the second week, 60.0 percent by the fourth week, 75.0 percent by the fifth week, 78.4 percent by week 12 and 66.7 percent at week 20. This antiviral effect is comparable or superior to that observed with previously tested combinations of antiretrovirals in this patient population. Furthermore, once-a-day administration of efavirenz may make it easier for patients or caregivers to adhere to therapy. Additional follow-up through the full 48-week course of the study will be important to determine if the drop in viral load is long-lasting and if the regimen will be well tolerated in children over time.

The study co-chair is Courtney Fletcher, Pharm.D., University of Minnesota, Minneapolis. Dr. Fletcher and Richard Brundage, Pharm.D., Ph.D., also of the University of Minnesota, are the protocol pharmacologists. Stephen Spector, M.D., University of California San Diego, is the protocol virologist. Dr. James McNamara and Dr. Lynne Mofenson are the NIAID and NICHD protocol medical officers.

Pharmaceutical support for this study was provided by DuPont Pharmaceuticals Company (efavirenz) and Agouron Pharmaceuticals Inc. (nelfinavir).

NIAID is a component of the National Institutes of Health (NIH). NIAID conducts and supports research to prevent, diagnose and treat illnesses such as HIV disease and other sexually transmitted diseases, tuberculosis, malaria, asthma and allergies. NIH is an agency of the United States Department of Health and Human Services.

###

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.


Story Source:

The above story is based on materials provided by National Institute Of Allergy And Infectious Diseases. Note: Materials may be edited for content and length.


Cite This Page:

National Institute Of Allergy And Infectious Diseases. "Study Shows Efavirenz Promising In Treating Pediatric HIV Infection: Leads To Approval Of New Drug For Treating HIV-Infected Children." ScienceDaily. ScienceDaily, 1 October 1998. <www.sciencedaily.com/releases/1998/09/980930142623.htm>.
National Institute Of Allergy And Infectious Diseases. (1998, October 1). Study Shows Efavirenz Promising In Treating Pediatric HIV Infection: Leads To Approval Of New Drug For Treating HIV-Infected Children. ScienceDaily. Retrieved August 1, 2014 from www.sciencedaily.com/releases/1998/09/980930142623.htm
National Institute Of Allergy And Infectious Diseases. "Study Shows Efavirenz Promising In Treating Pediatric HIV Infection: Leads To Approval Of New Drug For Treating HIV-Infected Children." ScienceDaily. www.sciencedaily.com/releases/1998/09/980930142623.htm (accessed August 1, 2014).

Share This




More Health & Medicine News

Friday, August 1, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Vaccine Might Be Coming, But Where's It Been?

Ebola Vaccine Might Be Coming, But Where's It Been?

Newsy (Aug. 1, 2014) Health officials are working to fast-track a vaccine — the West-African Ebola outbreak has killed more than 700. But why didn't we already have one? Video provided by Newsy
Powered by NewsLook.com
Study Links Certain Birth Control Pills To Breast Cancer

Study Links Certain Birth Control Pills To Breast Cancer

Newsy (Aug. 1, 2014) Previous studies have made the link between birth control and breast cancer, but the latest makes the link to high-estrogen oral contraceptives. Video provided by Newsy
Powered by NewsLook.com
House Republicans Vote to Sue Obama Over Healthcare Law

House Republicans Vote to Sue Obama Over Healthcare Law

Reuters - US Online Video (July 31, 2014) The Republican-led House of Representatives votes to sue President Obama, accusing him of overstepping his executive authority in making changes to the Affordable Care Act. Mana Rabiee reports. Video provided by Reuters
Powered by NewsLook.com
Uganda on Alert for Ebola but No Confirmed Cases

Uganda on Alert for Ebola but No Confirmed Cases

AFP (July 31, 2014) Uganda's health minister said on Thursday that there are no confirmed cases of Ebola in the country, but that it remained on alert for cases of the deadly virus. Uganda has suffered Ebola outbreaks in the past, most recently in 2012. Duration: 00:59 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins