Current Studies

Adult AIDS Clinical Trials Group (AACTG) Studies

AACTG 5175

The AACTG 5175 study aims to demonstrate the non-inferiority of a once-daily protease inhibitor (PI) and a once-daily non-nucleoside reverse transcriptase inhibitor (NNRT) regimen in comparison to a standard twice daily ARV therapy for initial treatment of individuals infected with HIV-1. The AACTG 5175 has the following associated sub-studies: A5185, A5199, and A5190.

A5185

The A5185 project examines genital secretions for HIV shedding before treatment and after one year of treatment to determine change in genital viral load.

A5199

A5199 studies the effects of the AACTG 5175 ARV treatment regimen on neurological function.

ACTG/IMPAACT 5190

This study enrolls infants of women who become pregnant while taking antiretrovirals while participating  in all NIH sponspored studies in order to monitor the effects of in-utero exposure to ART through 18 months.

ACTG 5221

The ACTG 5221 study examines the effects of delayed versus immediate anti-retroviral treatment in HIV-positive patients with tuberculosis.

ACTG 5230

ACTG 5230 is studying the outcomes of patients who fail first line ARV treatment and are subsequently treated with Kaletra monotherapy.

HIV Prevention Trials Network (HPTN) Studies

HPTN 052 Discordant Couples Study

This study’s objective is to determine whether antiretroviral therapy can reduce the risk of HIV transmission between HIV sero-discordant couples. Couples in which one member is HIV positive and has a CD4 count between 350-550 cells/mm3 and one is HIV negative are recruited and randomized to immediate initiation of ART or delayed initiation of ART (when the CD4 counts falls below 250cells/mm3)

HPTN 062

HPTN 062 was developed to evaluate both the acceptability and feasibility of an enhanced, individual-level counseling intervention aimed at reducing risk behaviors, for individuals in the acute and early phase of HIV infection. Secondarily this study will examine 1) participant risk behaviors and perceptions of infectiousness after the acute and early phases of HIV infection; and 2) the effectiveness of the intervention to reduce risky behaviors for HIV transmission. Participants in this study have acute HIV infection and are already enrolled in the CHAVI 001 study.

Malaria Vaccine 055

This is a phase III study to evaluate the safety and efficacy of the GSK Biologicals candidate malaria vaccine RTS,S/AS01E against malaria caused by P. falciparum infection. This clinical trial is concurrently taking place in a variety of African nations to adequately evaluate its efficacy within infants (6-12 weeks) and children (5–17 months) across diverse malarial transmission zones.

Center for HIV/AIDS Vaccine Immunology (CHAVI)

This multi-site study is being led by investigators at UNC at Chapel Hill, Duke University, University of Alabama, Harvard University and Cambridge University with collaborators from Asian and African sites. CHAVI is a 2 year observational study to determine: 1) how the immune system works in participants with acute HIV infection, established HIV infection and those who are HIV negative; 2) the characteristics and behavior of HIV; 3) the genetic factors affecting the progression of HIV. Participants in this study are individuals with acute HIV infection and their sexual partners, individuals with established HIV, and HIV negative people.

Methods for Prevention Program Packages (MP3)

MP3 is piloting an aggressive HIV transmission prevention program to identify persons with Acute HIV infection (AHI) and intervene behaviorally and biologically. The specific aims of the study are to: 1) Develop a novel program to prevent HIV transmission by identifying and informing persons with acute HIV infection in Lilongwe, Malawi, 2) Evaluate a short-term, combined behavioral and antiretroviral therapy (ART) intervention to prevent HIV transmission among persons with AHI, 3) Determine the potential individual and combined impact of each component of the intervention using mathematical modeling.

HIV Partner Notification Study

The study population for this study is patients testing HIV positive for the first time in the STI clinic and their sexual partners. This study will determine 1) which method of partner notification (passive referral, contract referral, and provider referral) results in the highest proportion of partners who receive HIV counseling and testing, and 2) the cost-effectiveness of these 3 referral methods. This study will also determine the acceptability of partner notification among index cases, partners, health care providers, and community members as well as the social harms associated with partner notification.

TrioPed Study

The aim of this study is to examine the effectiveness of Triomune baby (a pediatric fixed dose combination of d4T/3TC/NVP) in HIV-infected children <10kg and compare the effectiveness of a split adult fixed dose combination of d4T/3TC/NVP with Triomune baby for children 10kg and above. Eligible children <10kg start on Triomune baby and children 10kg and above are randomized to either Triomune baby or split adult FDC. TrioPed is taking place at Lighthouse, Martin-Preuss Centre and Baylor CoE in Lilongwe.

Karposi Sarcoma Diagnostics

Kaposi's sarcoma is the most common cancer in Malawi and is highly associated with HIV. The objective of the Kaposi Sarcoma Diagnostics Study is to determine the frequency of expression of certain genes and enzymes associated with Kaposi sarcoma-associated herpes virus that may be lead to alternative viral based treatments for the cancer.

SAFEST 2 Study

SAFEST 2 is a collaboration between UNC Project, Queen Elizabeth Central Hospital, and the Lighthouse clinic that is evaluating the safety and effectiveness of the current second line treatment in Malawi. Additionally, it evaluated the validity of the current failure definition in the ART program and described the degree of resistance that was present at the time of failure identification.

Burkitts Lymphoma

Endemic Burkitt Lymphoma (BL), an Epstein-Barr virus (EBV)-positive malignancy, is among the most common pediatric malignancies in sub-Saharan Africa. While the viral role in carcinogenesis continues to be elucidated, it may be possible to target the virus present within the tumor cells. BL can be synergistically killed by combining cytotoxic antitumor therapies with ganciclovir. We have recently extended these findings to show that cyclophosphamide (the primary agent used in treating BL in Malawi) can induce the lytic EBV life cycle in both EBV-positive B-cell lines and BL cell lines in vitro.  Demonstrating lytic EBV expression in BL following treatment with chemotherapy in vivo is important for developing a new approach of combining therapies to treating EBV-related malignancies.

IMPAACT P1060: Pediatric Exposed to Nevirapine (PEN) Study

The PEN study is comparing the responses to initiation of Non-nucleoside reverse transcriptase inhibitors (NNRTIs) versus protease inhibitor (PI)-based antiretroviral therapy in HIV infected infants who had and had not received single dose nevirapine (NVP) for PMTCT. The study’s primary objective is to compare rates of treatment failure at 24 weeks in subjects on an NVP based regime versus a Kaletra based regimen in Nevirapine exposed and non-exposed infants.

MTN 015

MTN 015 is an observational cohort study of women following HIV-1 seroconversion in microbicide trials. The study hypothesis is that exposure to study agents in MTN clinical trials will not impact the natural history of HIV-1 infection as measured by the virologic, immunologic and clinical outcomes of participants with HIV-1 seroconversion during microbicide trials.

Crypto Study

Cryptococcal meningitis is a leading cause of death in HIV-infected patients, estimated to kill 500,000 people in sub-Saharan Africa per year. In resource-rich countries the standard first-line treatment for HIV infected patients with cryptococcal meningitis is two weeks of intravenous amphotericin B with oral flucytosine. However, this regimen is relatively toxic and requires intense laboratory monitoring which cannot be delivered in most centers in sub Saharan Africa. In the first study phase, addition of flucytosine to high-dose fluconazole led to a marked improvement in antifungal activity. Building on these results, the addition of short course (one week) amphotericin B to high-dose fluconazole is currently being compared to high-dose fluconazole plus flucytosine. In addition, possible drug interactions between medications used to treat cryptococcal meningitis, TB and HIV will be studied by measuring their relative CSF and plasma concentrations at various time-points.

IUCD Pilot Study

It is estimated that 40.6% of pregnancies in Malawi are unintended, and unintended pregnancy and unsafe abortion contribute significantly to the high maternal mortality ratio in Malawi. Only about 39% of Malawian women use some form of modern birth control, and it is estimated that 45% of Malawian women have an unmet need for contraception. The most common modern methods of birth control in Malawi is the oral contraceptive pill, which has a failure rate of 8% with typical use. The intrauterine contraceptive device (IUCD) is one of the most effective reversible forms of birth control.  This is a pilot study to determine whether it is feasible to conduct a large clinical trail to compare insertion of a  Copper T380A intrauterine contraception immediately postpartum with the standard to 4-6 weeks postpartum insertion time.

IUCD in HIV+ Women Acceptability Study

This prospective, randomized study is to determine the medical eligibility, acceptance and adherence to the Copper T380 intrauterine contraceptive device compared to depo medroxyprogesterone acetate injection contraceptive among HIV+ women attending the Lighthouse Clinic in Lilongwe, Malawi.  Two hundred HIV+ women who meet study eligibility will be enrolled. This study is a collaboration between UNC Project and Emory University.

Pharmacokinetics of ARV and Oral Contreptives Study

This is a pilot study to determine the effect of combination antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women in Malawi.

Trauma Registry

Currently, the trauma registry collects detailed information on all injured patients seeking care at KCH, including data on the injury mechanism, pre-hospital transportation, injuries sustained, treatments, and outcome. The information gathered from the trauma registry assisted the KCH Department of Surgery in becoming certified as a training site for Malawian general surgeons. Furthermore, the trauma registry data is being compared to police reports to better elucidate the incidence of road traffic injuries in the Lilongwe district.

Cancer Registry

The cancer registry is a multi-disciplinary project that involves all departments at the Kamuzu Central Hospital. The objective of the study is to determine the frequency of all cancer among patients presenting to KCH and to evaluate the management of such cases.

Admission Registry

The objective of the admissions registry is to determine the number and reasons for hospitalization on the medical ward of Kamuzu Central hospital in order to optimize clinical care.