US researchers have upheld the findings of a 1997 Ugandan study that said the AIDS drug Nevirapine was safe and effective. The drug is widely used in Africa and other developing regions to prevent mother to child transmission of HIV.
The study had been called into question last year when flaws were uncovered in record keeping. But yesterday, the Institute of Medicine described the Ugandan study as “reasonable, scientifically sound and appropriate.
Dr. Philippa Musoke was the co-principal investigator in the Nevirapine study. She is a senior lecturer in the Department of Pediatrics at Makerere University in Kampala. Dr. Musoke spoke to English to Africa reporter Joe De Capua about the validation of the Ugandan study.
“Great relief and very exciting. Finally, here, after all the previous reports that were not so good about the conduct of the trial and about the safety of the drug, to finally hear that an independent committee has evaluated the conduct of the trial and found that the data is actually accurate. A relief for us at the site and was very exciting,” she says.
Dr. Musoke says she and her colleagues were surprised when criticisms arose over the study known as HIVNET 012. She says, “Obviously as investigators you do your best to follow the guidelines that have been provided for conducting research in an ethical manner.”
However, she says researchers did accept criticism over lapses in documentation. “But then,” she says, “it sort of got blown out of proportion, so it was a real surprise and things just escalated. You can imagine the study was started in 1997 and we’re still dealing with the same study.”
Dr. Musoke says the validation proves the importance and effectiveness of Nevirapine, as well as proving that valid research can be conducted in resource poor settings.