Student Names: Drisa Weinberg, Sara Eberline

Date: 9/30/08
Article Title: Short-Course Therapy with Zidovudine plus Lamivudine for Prevention of Mother-
to-Child Transmission of Human Immunodeficiency Virus Type 1 in Thailand.
Introduction
1. What is the purpose of this study? Did they adequately explain their reasons for
undertaking the study? Support your answer.
The purpose of the study is to administer short course therapy of width Zidovudine plus
Lamivudine for prevention of mother-to-child HIV transmission in Thailand. The study
did not adequately explain the importance of lowering mother-to-child transmission of
HIV. Also, the study assumed the reader had prior knowledge of the severity and
prevalence of the situation.
2. Was the background information provided adequate to understand the aims or objectives
of the study? Comment on this. If not enough information was provided, how could this
have been improved?

The article started with a short abstract and only briefly mentioned that other studies had
done the short course therapy and found it effective. To make this article more effective
the author should have provided background information such as: an educational
background on HIV and the drugs used in the therapy, elaborate on other related studies
and their effectiveness, and current statistics on mother-to-child transmission. If the
article would have included this information, the study would have made more of an
impact on readers who are not familiar with this issue.
Methods
1. List and briefly explain the methods used to collect the data. Were the methods described
in sufficient detail for others to repeat or extend the study? Support your opinion.
The first course of treatment was given to the mother starting at week 34 of gestation and
continued until the onset of delivery. This part of the therapy the mothers were orally
administered 300 mg of Zidovudine and 150 mg of Lamivudine twice per day. Once
onset of delivery occurred, the mothers were given the same doses of each drug every
three hours until delivery.
The second course of treatment involved the infants who received 2mg/kg of Zidovudine
syrup every six hours for four weeks. Venous blood samples were obtained at 1 to 2 days,
1 month, and 4 months of age in order to detect HIV 1 RNA and HIV 1 DNA, CD4 cell
counts, and complete blood cell counts. Specifically, at 12 and 18 months of age data was
collected for detection of anti-HIV 1 antibody. Also, they were scheduled for visits 1, 2,
4, 6, 9, 12, 15, and 18 months of age for routine check-ups and vaccination schedules.
 Lastly, liver and renal function tests were performed at one month of age and were only
continued if abnormalities were found.
The methods were not described in great sufficient detail for others to repeat or extend
the study. The authors explained what samples they collected, but not how they obtained
the collections.
2. Were methods that were developed previously by other investigators adequately
referenced?

The study does not mention previous methods developed by other investigators, however
it’s apparent that the study was not the first of its kind and other references contributed to
their methods.

3. Were methods developed by others modified? If so, were the modifications carefully
described?

Methods were not modified, because no other methods from previous studies were
mentioned in this article.

4. Have the authors indicated the reasons why particular procedures were used? If so, what
were their reasons?

The reasons for taking the sample collections from the infant were not disclosed, however
it seem evident that an HIV RNA and DNA test would be preformed in order to
determine whether the infants were HIV positive or negative.

5. Have the authors indicated potential problems with the methods used? If not, do you feel
that they should have and why?
The authors indicate that intolerance to Zidovudine and Lamivudine would present
problems, so mothers with this intolerance did not continue in the study. Other potential
problems involving the treatment of the infants were not discussed.
6. Have the author specified the statistical tests and procedures used? If so, what were they?
How did the authors convey the statistical results?
 The authors specified the preformed statistical tests: CD4 count, CD8 count, and virus
load in the HIV positive mothers enrolled in the study. Also, the statistical tests for the
infants who still developed HIV with the treatment included: CD4 counts, hemoglobin
concentration, etc. The authors conveyed the statistical results for both the HIV positive
mothers and infants by a graph and several charts.

Results

1. Was this a descriptive or experimental study? If experimental, were the experiments done
appropriate to the aims or objective of the study? If this was not an experimental study,
was the design appropriate? Support your answer.

The study was conducted as an experiment. The experiments or tests collected from the
mothers and infants were both aimed to see the effect of Zidovudine and Lamivudine on
lowering mother-to-child HIV transmission.

2. What were the results of the study? Do the results make sense to you? Support your
opinion.
The results were that there was a 2.83% transmission rate from mother to child. Of out
the 106 infants only 3 tested positive for HIV-1. The study determined that there is no
correlation between the number of dosages of zidovudine and lamivudin administered
before giving birth and the amount of virus being made the CD4+ increase.
At the start of the study the CD4+ count was a median of 274 cells/mm3 at time of
delivery the median was 376 CD4+ cell/mm3 and after birth it rose again the 538 CD4+
cell/mm3.Although the CD4+ increased throughout the study the viral load decreased
from the time of enrollment to the time of birth and then increased again after the women
gave birth. The CD8+ stayed stable throughout the experiment. We agree that the increase
of the CD4+ and the decrease on the amount of HIV virus being made by the body of the
mother would make her less likely to transmit the virus to her infant. The study does not
explain in depth why there is no correlation between the number of doses of the
zidovudine and lamivudin the increase CD4+ and decrease in HIV virus being made.
3. Do the figures and tables clearly present the data? Are the legends adequate? Support
your answers. The graph shown does adequate job of presenting the data the legend is
easy to understand. It does accurately show that the CD4+ increased throughout the
study and the HIV virus decreased at birth and increased after birth.

Discussion
 1. Were the aims or objectives of the study met? Why or why not?
The objective of the study is to decreased transmittion rate of HIV from mother to child
though the use of the drugs zidovudine and lamivudin. The objective were met
because only 3 out of 106 infants tested positive for HIV.

2. Do the authors discuss their results in relation to previous studies?

The compared their ruslts with two different studies PETRA and a French study. The
PETRA study used the same two drug to do short course therapy on infants to compare
breastfed vs formula feed tranmittion rate. They determined that that there was very little
difference. The French study long course therapy treatment of zidovudine and a short
course of lamivudine and the results were the same as this study.

3. Do the authors indulge in needless speculation?

No.
4. Do the authors adequately interpret the data? Comment on this.
They compare the data to other studies and they dicuss the effection of tranmisstion to
having other health complication associatied with HIV.
5. Do the authors discuss the limitations of this study? What are the limitations?
Since there was a lack of funding they were unable to do a control group.

References

1. Do the authors cite appropriate papers for comments made?

They have 19 refencense listed each relateing to HIV transmition and health realted
concerns.
2. Do the authors cite their own publications needlessly?
No they do not cite there own work
Abstract

1. Is the abstract or summary at the beginning of the article intelligible? Comment on this.
 From the abstract, the reader can understand the purpose, methods, results, and
conclusion of the study making it intelligible and helpful to the reader in understanding
all aspect of the study.

2. Does the abstract accurately describe the study and the results? Comment on this.

The abstract accurately describes the methods taken throughout the study on both the
mother and the infant. The abstract explains the results by restating that 100 HIV positive
mothers were initially involved in the study and throughout their pregnancy and birth 3
infants became infected with the virus. More specifically, the abstract concludes a 2.83%
HIV transmission rate mother-to-child throughout the experiment.

3. Does the abstract include material that cannot be substantiated? Comment on this.

One conclusion expressed in the abstract contained material that could not be proven by
the information provided in the abstract or experiment as a whole. At the end of the
abstract the authors’ state, “Short-course therapy with Zidovudine plus Lamivudine
appeared to be safe and effective for prevention of perinatal transmission of HIV-1”.
Though this did appear to be true, the authors did not show evidence of either the current
rates of perinatal transmission or other techniques effectiveness of prevention of perinatal
transmission, making it unclear how effective the Zidovudine plus Lamivudine technique
really was.