Trial of tenofovir as a prophylactic against HIV suspended

NIGERIA: Trial of tenofovir as a prophylactic against HIV suspended

DAKAR, 29 Mar 2005 (PLUSNEWS) - Nigeria has become the third country to halt clinical trials of the antiretroviral (ARV) drug tenofovir as a prophylactic against HIV after the US-based supervisor of the trials found that proper standards were not being observed.

"Regrettably, the tenofovir study in Nigeria will not be continuing because FHI has determined that the study team is not at this point able to comply with all of the standards that have been established for conducting this study," Family Health International (FHI) said in a statement earlier this month.

Tenofovir is an ARV drug that is widely used to treat people living with AIDS, but trials of the drug as a prophylactic that might stop people contracting the virus have been dogged by controversy.

FHI has also been forced to suspend trials of tenofovir as a prophylactic in Cambodia and Cameroon because of concerns about the way in which sex workers who volunteered to take part in the experiment were being treated.

Beth Robinson, a member of FHI's research department in the United States, told PlusNews that the clinical trial in Nigeria involved 130 sex workers in the southwestern city of Ibadan and had been under way since July 2004.

The trial had been supervised by a doctor from the Faculty of Medicine of Ibadan University, but doubts had arisen over the quality of controls which the physician and his team had exercised, she said.

"During the course of five visits to the test sites in recent months, it was apparent that the local teams were having problems in following the correct procedures in the laboratory and also on the ground," Robinson said without elaborating.

She pointed out that the sex workers who were taking part in the Nigerian trials would receive free follow-up medical care for three months following their suspension.

Last February, a wave of protests by AIDS advocacy groups in France and Cameroon persuaded the government of Cameroon to halt similar tenofovir trials being carried out by FHI on sex workers in the port city of Douala.

The Ministry of Health ruled that the women taking part were not sufficiently aware of the risks involved, and had not been provided with health care should they become infected with HIV during the course of the trials.

Tenofovir is manufactured by the California-based pharmaceutical company Gilead Sciences and has been sold under the brand name Viread for the past three years.

Laboratory testing of tenofovir on monkeys proved 100 percent successful in preventing them from contracting the simian version of HIV, so human trials on the use of tenofovir as a prophylactic began last year.

Despite their suspension in Cambodia, Cameroon and Nigeria, these trials are still under way in Ghana and among males from the gay communities of Atlanta and San Francisco in the United States.

Further clinical trial are due to start in Malawi and Botswana.

Selected sex workers are tested for HIV and are then given one tenofovir pill per day or a placebo over a period of several months. At the end of the programme, the women are tested again to see whether they are still free of the virus.

FHI says that all the women taking part in the African trials have access to condoms and health facilities during the course of the programme. But women sex workers on the streets of Africa don't always dictate the terms of their trade, as many of their clients refuse to wear a condom.


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