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April 7, 2005

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QUESTIONS AND ANSWERS
The HIVNET 012 Study and the Safety and
Effectiveness of Nevirapine in Preventing
Mother-to-Infant Transmission of HIV


1.

Is single-dose nevirapine a safe and effective drug for the prevention of mother-to-infant transmission of HIV?

Single-dose nevirapine is a safe and effective drug for preventing mother-to-infant transmission of HIV. This has been proven by multiple studies, including the HIVNET 012 study conducted in Uganda (see Selected Bibliography).

2.

Has the scientific validity of the HIVNET 012 study findings been independently evaluated?

The National Institutes of Health contracted with the Institute of Medicine (IOM), part of the National Academies of Sciences, to conduct an independent review of the design, conduct, results and validity of the HIVNET 012 perinatal HIV prevention study. In September 2004, the IOM convened a committee that began this assessment. The committee evaluated extensive materials from a variety of sources and reviewed primary source documents from Uganda.

On April 7, 2005, the IOM publicly released the report of the committee. As the report summarizes,

“Based on its review, the committee finds no reason to retract the publications or alter the conclusions of the HIVNET 012 study. The committee concludes that data and findings reported in Guay et al. (1999) and Jackson et al. (2003) are sound, presented in a balanced manner, and can be relied upon for scientific and policy-making purposes.”

The IOM report (Review of the HIVNET 012 Perinatal HIV Prevention Study) and news release concerning the report are available on the Web.

3.

An Associated Press news story issued December 13, 2004, states "...top U.S. health officials [at the National Institutes of Health] were warned that research on the key drug [nevirapine] was flawed and may have underreported thousands of severe reactions including deaths...." Is this true?

This statement quoted from that December 2004 news article stands in stark contrast to the conclusions of the IOM review, released in April 2005, which confirmed the soundness of the previously published scientific papers that included data on serious adverse reactions in HIVNET 012 (see Q&A #2).

The statement in the Associated Press article of December 13, 2004, that there may have been thousands of underreported serious adverse events in the HIVNET 012 study implies that those were due to the drug nevirapine. This implication is absolutely false. Remonitoring reports of HIVNET 012 found no additional serious adverse reactions related to nevirapine. The original published study and the multiple subsequent reviews of the HIVNET 012 trial that have carefully scrutinized its data have found only a very small number of serious adverse reactions that potentially might be due to nevirapine.

HIVNET 012 compared the safety and efficacy of preventing mother-to-infant HIV transmission using an AZT regimen versus a nevirapine regimen. In the six weeks following treatment, among the 309 infants in the AZT arm of the trial, 38 infants experienced serious adverse events, seven of which were thought possibly to be due to AZT. In the 320 infants who received nevirapine, 35 infants experienced serious adverse events, only two of which were thought to be possibly due to nevirapine. In the 302 mothers in the AZT arm of the trial, 12 experienced serious adverse reactions, and only one was thought possibly to be due to AZT. Of the 306 mothers who received nevirapine, 16 experienced serious adverse events, and only one was thought possibly to be due to nevirapine.

4.

The same December 13th Associated Press news story alleges that NIH officials chose not to inform the White House in the spring of 2002 about safety issues concerning nevirapine. Is this true?

There is no truth to the allegation that NIH officials chose not to inform the White House in the spring of 2002 about safety issues concerning nevirapine. No direct report to the White House was necessary, because there were no new data that changed the conclusion of the initial HIVNET 012 report, that is, that single-dose nevirapine is a safe and effective regimen for blocking mother-to-infant HIV transmission.

A review conducted in early 2002 had identified procedural problems related to record-keeping in the conduct of HIVNET 012, findings that were publicly disseminated by NIAID (see Review of HIVNET 012) and discussed widely in the media. However, this early 2002 review and multiple subsequent reviews initiated by NIAID and NIH never called into question the safety and efficacy of the single-dose nevirapine regimen.

Of note, in the weeks prior to the President’s announcement of his $500 million program to prevent mother-to-infant HIV transmission in Africa, senior NIAID officials specifically queried NIAID Division of AIDS staff involved in the conduct and review of HIVNET 012 on this issue; they confirmed that procedural problems identified in early 2002 had no bearing on the proven safety and efficacy of the single-dose nevirapine regimen. The Institute of Medicine report of April 2005 confirms the validity of the safety and efficacy data concerning nevirapine as previously reported in the scientific articles about HIVNET 012 published in 1999 and 2003.

5.

Associated Press stories published December 13 and 14, 2004, also report allegations of scientific and administrative misconduct by staff within NIAID's Division of AIDS. Are these allegations true?

An individual has made several allegations regarding the scientific and professional conduct of officials at NIAID's Division of AIDS and of the scientific validity of the findings from the HIVNET 012 study. The allegations of misconduct have been assessed by the NIH Office of the Director using standard NIH protocols for handling this type of allegation and have been found to have no merit.

Moreover, the Institute of Medicine report of April 2005 confirms the scientific validity of the HIVNET 012 study findings.

6.

Various media outlets have reported allegations that the Director of the NIAID Division of AIDS inappropriately “altered” or even “doctored” a re-monitoring report related to the HIVNET 012 trial conducted in Uganda. Are these allegations true?

These allegations are completely false.

As Director of the NIAID Division of AIDS (DAIDS), Dr. Edmund Tramont had the overall responsibility for generating a re-monitoring report concerning HIVNET 012. Input for this final omnibus report came to him from DAIDS staff members responsible for several draft “subreports” related to various aspects of HIVNET 012. This input included draft subreports from those staff members sent by DAIDS to Uganda to execute the re-monitoring of HIVNET 012.

Dr. Tramont edited several of these subreports (including the January 2003 submission from the individual responsible for the safety subreport) to make sure that the subreports accurately reflected the entire re-monitoring process. The safety subreport submitted by a staff member in January 2003 and mentioned in media reports did not reflect all the information available at that time. Dr. Tramont, in accordance with his responsibility for the entire report, included more extensive and comprehensive information in his omnibus report, including data from re-monitoring reports generated by Westat Inc., PPD Development Inc., EMMES Corporation, and the seven DAIDS staff who conducted three re-monitoring site visits in Uganda. The Institute of Medicine essentially conducted their own remonitoring report by examining source documents from Uganda. Their conclusion, similar to that of Dr. Tramont, was that HIVNET 012 showed that nevirapine was safe and effective in preventing mother-to-infant transmission of HIV.

7.

Why is NIAID deeply concerned about the consequences of the distortion of facts that has resulted from the recent publicity about the HIVNET 012 trial conducted in Uganda?

As a result of distortions of facts resulting from the recent press reports concerning nevirapine and the HIVNET 012 trial, there is a real possibility that physicians and health care providers in developing countries will not use the lifesaving single-dose nevirapine regimen to block mother-to-infant transmission of HIV in situations where there are no other options, such as multiple drug antiviral treatments. NIAID stands by the results of HIVNET 012 and the safety and efficacy of single-dose nevirapine to prevent mother-to-infant transmission of HIV. Furthermore, as stated in the IOM report of April 2005, the results of the HIVNET 012 study “…can be relied upon for scientific and policy-making purposes.” This lifesaving approach is also endorsed by multiple groups, including:

World Health Organization

Elizabeth Glaser Pediatric AIDS Foundation

Global Strategies for HIV Prevention

Project Inform

It is conceivable that thousands of babies will become infected with HIV and die if single-dose nevirapine for mother-to-infant HIV prevention is withheld because of misinformation.

NIH and NIAID Statements and News Releases

NIH Statement on the IOM Study of the HIVNET 012 Perinatal HIV Prevention Trial

Reports on Nevirapine Threaten Public Health (PDF)

The HIVNET 012 Study and the Safety and Effectiveness of Nevirapine in Preventing Mother-to-Infant Transmission of HIV

Thai Study Shows That Inexpensive Treatment Reduces Risk Of Mother To Child HIV Transmission

Nevirapine Sustains Advantage Over AZT During Breastfeeding Period

Review of HIVNET 012

Inexpensive AIDS Drug Still Reduces HIV Transmission from Mother to Child After One Year

Researchers Identify a Simple, Affordable Drug Regimen That is Highly Effective in Preventing HIV Infection in Infants of Mothers With the Disease

NIAID Letter to the Editor: Maligned HIV Drug has Prevented Deaths

Links

Disclaimer: The National Institute of Allergy and Infectious Diseases does not assume responsibility for information obtained beyond this point. Please click the "Back" button of your browser to return to this page.

Institute of Medicine Review of the HIVNET 012 Perinatal HIV Prevention Study

IOM Report Confirms Safety of Nevirapine to Prevent Mother-to-Child Transmission of HIV, Signals Movement Forward: Elizabeth Glaser Pediatric AIDS Foundation Now Urges Expansion of Drug Options for HIV-positive Pregnant Women in the Developing World

WHO: Nevirapine for the Prevention of Mother to Child Transmission of HIV

WHO: Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants

Elizabeth Glaser Pediatric AIDS Foundation on Issue of Prevention of Mother-To-Child Transmission of HIV/AIDS and Single-Dose Nevirapine

Statement by MU-JHU Research Collaboration Investigators

British Medical Journal: Articles Criticising Nevirapine Trial May Endanger Babies' Lives

AIDS Treatment News: Nevirapine Misinformation: Will It Kill?

Global Strategies for HIV Prevention: Comments on a Recent Media Article on the HIVNET 012 Uganda Study

Global Strategies for HIV Prevention Web Site

Project Inform Statement Regarding the Use of Single-Dose Nevirapine to Prevent Mother-to-Child Transmission of HIV

Statement: Boehringer Ingelheim Provides Key Background on Viramune®

Voice of America: South African Doctor (Jerry Coovadia) Says Benefits Of Nevirapine Outweigh Any Risks: Text summary

New Vision, Kampala, Uganda: Nevirapine Critics are Just Malicious

U.S. Department of Health and Human Services HIV/AIDS Treatment Guidelines

National Public Radio: Arguing an AIDS Drug for Mothers

National Public Radio: U.N. Urges Use of AIDS Drug in Africa

U.S. Department of State: Exaggerated Concerns About Anti-AIDS Drug Nevirapine: Media allegations that anti-AIDS drug causes severe reactions disproved

Selected Bibliography

###

Media inquiries can be directed to the NIAID OCPL media group at 301-402-1663.

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

Prepared by:
Office of Communications and Public Liaison
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892

U.S. Department of Health and Human Services


NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health ®

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Last Updated April 07, 2005