Mwanachingwala querries MDP over failed gel trials

Mwanachingwala querries MDP over failed gel trials
By Henry Chibulu in Mazabuka
Sun 03 Jan. 2010, 04:00 CAT

CHIEF Mwanachingwala of Mazabuka has said he is not ready to meet officials from the Microbicide Development Programme (MDP) unless the organisation explains how 46 women contracted HIV during the failed microbicide gel clinical trials.

He told MDP Community Liaison officer Kennedy Mundia that he and his workmates should not expect to go scot-free after administering a gel on poor and uneducated women that has resulted in women contracting HIV.

Chief Mwanachingwala said he could only meet the officials at the palace after the organisation has met his conditions that include compensation of the affected victims.

The irate traditional leader who could not give time to Mundia to explain what transpired however said it was pointless for him to engage in dialogue with the organisation now because it could not reverse the current status.

Chief Mwanchingwala charged that MDP allegedly recruited uneducated women who did not understand the nature of the clinical trials and its consequences.

But Mundia pleaded with the chief to allow MDP officials visit him at the palace so that they could explain what transpired.

However, no official date for the visit was fixed during the heated debate in which chief Mwanachingwala, among other things, called for the prosecution of the initiators of the programme.

Chief Mwanachingwala has since called on the government to be careful in recommending organisations carrying out research on HIV to protect vulnerable women from contracting HIV and AIDS.

The gel was administered on women an hour before any sexual encounter. This was done to determine the efficacy of the drug called PRO 2000.

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From back in Februari:

Indevus Pharmaceuticals Announces PRO 2000 Found To Show Promise In Large HIV Prevention Study
Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry
Article Date: 10 Feb 2009 - 0:00 PDT

The HIV Prevention Trials Network (HPTN) 035 trial was a multi-national, randomized, placebo-controlled trial to assess the safety and effectiveness of PRO 2000 and another investigational vaginal microbicide (BufferGel(R), ReProtect, Inc.) in preventing HIV infection in women. The trial was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH, and conducted by the NIH-funded Microbicide Trials Network (MTN) at seven clinical centers in Malawi, Zimbabwe, South Africa, Zambia, and the United States..

The trial was initiated in February 2005 and enrolled approximately 3,100 eligible, HIV-uninfected women, all of whom provided written informed consent. Enrolled participants were randomly assigned to one of four arms: PRO 2000 gel (0.5% strength), BufferGel, a placebo gel, or no gel. Women enrolled in the three gel arms were asked to apply the assigned study product vaginally up to one hour before each act of sexual intercourse. The gel arms were double-blinded so that neither the participant nor the study staff knew the identity of the assigned study product. Women in all four arms received a standard-of-care HIV prevention package, which included free male condoms, risk-reduction counseling, and treatment of sexually transmitted infections. Participants were followed for 12-30 months (20 months on average), depending on when they entered the study..

A total of 194 new HIV infections occurred among study participants over the course of the trial. Of these, 36 occurred in the PRO 2000 arm, 54 in the BufferGel arm, 51 in the placebo arm, and 53 in the no-gel arm. Based on these data, PRO 2000 was 30 percent effective (approximately 33 percent effectiveness would have been considered statistically significant). The adverse event profile was similar in all four arms, indicating that 0.5% PRO 2000 is safe for vaginal use. A full analysis of the trial data is underway..

The study was conducted in communities where the background rate of HIV infection is high. Participants who became infected with HIV during the trial were referred to local HIV care and support services. Where possible, infected participants were invited to participate in Microbicide Trials Network (MTN) 015, a clinical study examining the nature of HIV progression and treatment response in HIV-positive women who had been using a topical microbicide or oral antiretrovirals as an HIV preventive measure when they acquired HIV infection..

A second large trial testing the safety and effectiveness of the 0.5% dose of PRO 2000 is currently underway. This trial is being sponsored by the United Kingdom's Medical Research Council (MRC) and conducted by the Microbicides Development Programme (MDP), an international partnership of researchers established to develop microbicides for the prevention of HIV transmission. Study MDP 301 is a multi-national, randomized, double-blind, placebo-controlled Phase III trial designed to examine the safety and effectiveness of PRO 2000 in preventing HIV infection in women. As in the HPTN 035 trial, all participants receive free condoms, risk-reduction counseling, and treatment for sexually transmitted infections. Approximately 9,400 women have been enrolled at study sites in South Africa, Tanzania, Uganda, and Zambia. The trial is expected to be completed during the summer of 2009..

Should PRO 2000 be shown conclusively to be safe and effective, Indevus intends to seek worldwide marketing approvals, and plans to work with government agencies and other organizations to help ensure affordable access to the product in resource-limited settings where the need is greatest..

According to statistics from UNAIDS and the U.S. Centers for Disease Control and Prevention, nearly half of the 33 million people living with HIV/AIDS worldwide are women. Most HIV infections in women are due to heterosexual intercourse. Moreover, women are twice as likely as their male partners to acquire HIV during sex, due in part to biological factors that make women more vulnerable. Although correct and consistent use of male condoms has been shown to prevent HIV infection, women often cannot negotiate condom use with their male partners. A safe and effective vaginal microbicide could offer a readily available approach for many women who cannot simply rely on condoms or abstinence as methods for protecting themselves from HIV. Even a partially effective microbicide could have a profound impact on the dynamics of HIV transmission. According to mathematical modeling conducted by the London School of Hygiene and Tropical Medicine, 2.5 million HIV infections could be averted over three years if a microbicide with 60 percent effectiveness were used in 73 low-income countries..