Adult Treatment

In 1996, PHRU was one of the first groups able to provide antiretroviral treatment through engaging in clinical trials and through actively seeking funding for treatment access programmes. The South African government started providing treatment in public facilities in late 2004, however there is still limited access to treatment in the public sector and the PHRU treatment Access and clinical trials continue to supplement these efforts. Dr Lerato Mohapi heads the adult treatment division.

Clinical trials

PHRU has been involved in more that 20 adult HIV treatment trials with various pharmaceutical companies and the AIDS Clinical Trials Group (ACTG), with currently15 ongoing protocols (8 ongoing trials and 7 post-protocol treatment programmes).

Current pharmaceutical company sponsored trials include:

• APV30005 An open label phase III trial assessing the long-term safety profile of one of its investigational drug-containing regimens in HIV-infected subjects. GlaxoSmithKline
• A4001026 A randomized, double-blind, comparative trial of a novel CCR5 antagonist, in combination with Zidovudine/Lamivudine versus Efavirenz in combination with Zidovudine/Lamivudine for the treatment of antiretroviral-naïve HIV-1 infected subjects. Pfizer Laboratories
• TMC278-C204 A Phase IIb randomized, partially blinded, dose-finding trial of TMC278 in antiretroviral naive HIV-1 infected subjects. Tibotec
• TMC114-C211 A randomized, controlled, open label trial to compare the efficacy, safety and tolerability of TMC114/RTV versus LPV/RTV in treatment naïve HIV infected subjects. Tibotec
• M06-802 A phase III, randomized, open label study of Lopinavir /ritonavir tablets 800/200mg once daily versus 400/100 twice daily when co administered with nucleoside/nucleotide reverse-transcriptase inhibitors in antiretroviral-experienced, HIV-1 infected subjects. Abbott Laboratories
• TMC114-TiDP31-C229 A randomized, open label trial to compare the efficacy, safety and tolerability of Darunavir/rit(800/100mg) qd versus DRV/RIT (600/100) bid in early treatment experienced HIV infected subjects. Tibotec

The unit is also an AIDS Clinical Trials Group (ACTG) Clinical Research Site (CRS)

Current ACTG trials are:

A5208/OCTANE- Optimal Combination Therapy After Nevirapine Exposure. This is a parallel randomized clinical trials,comparing the responses to NNRTI-based and PI-based antiretroviral therapy in HIV-infected, treatment naïve women who have and have not previously received single dose Nevirapine MTCT prophylaxis.

A5221 A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for HIV-Infected Persons Treated for Tuberculosis with CD4 <200 Cells/mm 3

Treatment Access Programme

The PHRU treatment access programme (PTAP) was set up in 2004 when ART was not widely accessible in the public health system. The programme provides access to care and antiretroviral treatment for PHRU clients. The programme was initially funded by a supplementary NIH grant to the CIPRA-SA Safeguard the Household which was transferred to USAID-PEPFAR in February 2008.

Since it’s inception in 2004, the programme has aimed to assist in meeting the global goals of the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat 2 million HIV-infected individuals and those orphaned by HIV/AIDS, in 15 focus countries over a 5-year period.

Most South Africans who require HIV treatment care and support receive it through the Government comprehensive care, management, and treatment of HIV and AIDS (CCMT) sites. Since its inception in 2004, the PTAP has endeavored to complement and support the Government by offering ARV treatment at the PHRU.

The scale up of enrolment into the programme continues and there is an increase in the number of patients who actively seek care, support, and antiretroviral treatment in the programme.

This USAID-PEPFAR funded programme has enabled the PHRU to provide HIV treatment and care to more than 1500 adults and children to date

The antiretroviral drugs used in this treatment access programme are the standard registered drugs available in South Africa and this programme follows the South African Government Management and Treatment Plan for HIV and AIDS for Children and Adults. Most patients are still on their first line regimens and continue to respond well to their treatment.

The programme also offers psychosocial support to patients and their families and as adherence to therapy is essential for the success of antiretroviral treatment it also offers pre-treatment and ongoing treatment adherence counseling

Collaboration with other research sites is to be forged and data collected in the programme has been used for presentations in local and international conferences by both the collaborators and the programme staff. This sharing of information with other programmes and those involved in HIV research and treatment is particularly important as it is essential in informing healthcare workers how best to address challenges that are common to sites in similar setting.