Gita Ramjee

South African Medical Research Council | MRC · HIV Prevention Research Unit

To determine risk factors for sexually transmitted infections (STIs) among women in Durban and Hlabisa (South Africa), Moshi (Tanzania), and Lusaka (Zambia). Between 2003 and 2004, 958 women at risk of STIs were enrolled in a 1-year prospective study. They were interviewed at each monthly visit, and samples for STI testing were collected during qua...

We examined diaphragm adherence among 2429 women randomized to the intervention arm (diaphragm + gel + condoms) in Methods for Improving Reproductive Health in Africa, a phase III trial of the diaphragm for HIV prevention in Zimbabwe and South Africa. Women were followed for a median of 7 quarterly visits (range: 1-8 quarterly visits) during which...

The extent to which human immunodeficiency virus (HIV-1) infection impacts on the ability to mount an effective immune response to HPV is unknown, but is relevant in planning HPV vaccine strategies for HIV-1 infected individuals. This longitudinal study investigated changes shortly after HIV-1 seroconversion on cervical HPV types and HPV-16 antibod...

Female-initiated HIV-prevention options, such as microbicides, are urgently needed. We assessed Carraguard, a carrageenan-based compound developed by the Population Council, for its efficacy and long-term safety in prevention of HIV infection in women. We undertook a randomised, placebo-controlled, double-blind trial in three South African sites in...

Contraceptive care for women in high HIV-prevalence settings has saliency for multiple health outcomes. This study assesses pregnancy prevention practices of physicians and nurses in South Africa, where HIV prevalence among women of childbearing age has increased sharply to 30%. Almost half of pregnancies are unintended, and vertical transmission o...

CONSORT Checklist (0.06 MB DOC)

Trial Protocol (1.00 MB DOC)

Recently revised statistics show the number of individuals living with HIV at over 33 million worldwide, with 68% being in sub-Saharan Africa. Current HIV prevention methods, such as condom use, monogamy and abstinence, are not always feasible. The need for improved HIV preventative technologies remains urgent. Of these, microbicides represent a pr...

Women make up more than 50% of adults living with human immunodeficiency virus (HIV) infection or the acquired immunodeficiency syndrome (AIDS) in sub-Saharan Africa. Thus, female-initiated HIV prevention methods are urgently needed. We performed a randomized, double-blind, placebo-controlled trial of cellulose sulfate, an HIV-entry inhibitor formu...

BACKGROUND: Women make up more than 50% of adults living with human immunodeficiency virus (HIV) infection or the acquired immunodeficiency syndrome (AIDS) in sub-Saharan Africa. Thus, female-initiated HIV prevention methods are urgently needed. METHODS: We performed a randomized, double-blind, placebo-controlled trial of cellulose sulfate, an...

To help fill the gap concerning health care providers' and policy makers' knowledge of and views concerning microbicides, we compared data from one U.S. study and two South African studies that explored these issues. Frontline providers in South Africa were enthusiastic about any method that would have the potential to slow the HIV/AIDS epidemic, w...

We evaluated the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens) and condoms compared to condoms alone on the incidence of chlamydial and gonococcal infections in an open-label randomized controlled trial among women at risk of HIV/STI infections. We randomized 5045 sexually-active women at three sites in Southern Africa. Par...

To evaluate the preparedness for phase 2/IIb/III microbicide trials at 4 clinical trial sites: Durban and Hlabisa (South Africa), Lusaka (Zambia), and Moshi (Tanzania). A prospective cohort study was undertaken to assess site suitability for microbicide efficacy studies. Study objectives included assessing sites' ability to recruit and retain high-...

More individuals were newly infected with HIV in 2005 than any other year. Sub-Saharan Africa and especially southern Africa bears the brunt of this pandemic. Although the picture in sub-Saharan Africa is largely one of a 'stable' epidemic where AIDS-related mortality is matched by the incidence of new infections, some countries in the Southern reg...

To assess the safety of the candidate microbicide Carraguard gel in HIV-positive women and men. A randomized, placebo-controlled, triple-blinded clinical trial of Carraguard gel when applied vaginally once per day for 14 intermenstrual days by sexually abstinent and sexually active HIV-positive women; and when applied directly to the penis once per...

From 2003 to 2006, the number of human immunodeficiency virus–infected people in sub-Saharan Africa able to access antiretroviral therapy (ART) has increased from 100,000 to >1 million. The World Health Organization estimates that >3.5 million patients are still in need. The challenges to more expeditious provision of ART in Africa are many. This a...

The researchers who conducted the cellulose sulphate microbicide trial share the lessons they learned from the trial's early closure.

Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe. We did an open-label, randomised controlled trial in HIV-negative, sexually active women...

When on the market, microbicides are likely to be used by individuals who do not know their HIV status. Hence, assessment of safety and acceptability among HIV positive men and women is important. Acceptability of Carraguard, the Population Council's lead microbicide candidate was assessed in a Phase I safety study among healthy HIV-positive sexual...

The promise of microbicides as an HIV prevention method will not be realized if not supported by health care providers. They are the primary source of sexual health information for potential users, in both the public and private health sectors. Therefore, the aim of this study was to determine perceptions of vaginal microbicides as a potential HIV...

The envelope genes of 23 subtype C viral isolates from five individuals with early HIV-1 infection, followed for 2-4 years, were sequenced, analyzed, and correlated to coreceptor usage. Isolates from three participants used the CCR5 coreceptor at all time points, with no significant adaptations in the variable loop lengths, predicted N-linked glyco...

This study investigated the effectiveness of a nonoxynol-9 (52.5mg, 3.5%), vaginal gel (Advantage S), in the prevention of human papillomavirus (HPV) infection in female sex workers. We showed by HPV DNA determination in cervico-vaginal rinses a significant increase in multiple (>1) HPV infection in HIV-1 seropositive women compared with HIV-1 sero...

We examined perceptions of the effectiveness and acceptability of a candidate microbicide among 94 South African female sex workers who had participated in a phase 3 microbicide trial for HIV prevention. Sixteen focus groups were conducted in 2001, 12 to 15 months after participants were informed that the candidate microbicide had been determined t...

More individuals were newly infected with HIV in 2005 than any other year. Sub-Saharan Africa and especially southern Africa bears the brunt of this pandemic. Although the picture in sub-Saharan Africa is largely one of a stable epidemic where AIDS-related mortality is matched by the incidence of new infections some countries in the Southern region...

Current HIV/AIDS statistics show that women account for almost 60% of HIV infections in Sub-Saharan Africa. HIV prevention tools such as male and female condoms, abstinence and monogamy are not always feasible options for women due to various socio-economic and cultural factors. Microbicides are products designed to be inserted in the vagina or rec...

This study investigated the impact of prevalent and incident HSV-2 infection on the incidence of HIV-1 infection in a cohort of female commercial sex workers in KwaZulu-Natal, South Africa. Prior to a vaginal microbicide trial, 416 women were screened for antibodies to HIV-1 and herpes simplex virus-2 (HSV-2) infections and a questionnaire was used...

This study investigated the impact of prevalent and incident HSV-2 infection on the incidence of HIV-1 infection in a cohort of female commercial sex workers in KwaZulu-Natal, South Africa. Prior to a vaginal microbicide trial, 416 women were screened for antibodies to HIV-1 and herpes simplex virus-2 (HSV-2) infections and a questionnaire was used...

With growing recognition of the potential value of microbicides for HIV/STI prevention, the importance of the acceptability of this brand-new technology has been widely acknowledged. We review the current body of microbicide acceptability research, characterize the limitations in assessment approaches, and suggest strategies for improvement. Electr...

Viral population diversity was assessed in samples collected from five HIV-infected women who were RNA positive and antibody negative. Similar to studies in men, highly conserved viral variants were detected (mean nucleotide diversity of 0.11% for p17p24, 0.32% for C2C3). In two individuals diversity was uncharacteristically lower in env C2C3 than...

This longitudinal study aimed to determine the incidence and pathogenic implications of dual human immunodeficiency virus type 1 (HIV-1) infection in a cohort of female sex workers. Blood samples from 31 recently infected women were screened by use of a heteroduplex mobility assay and sequencing. The median viral load set point was 5404 copies/ mL...

To evaluate the acceptability of COL-1492, a vaginal gel containing 52.5 mg nonoxynol-9, in an HIV prevention trial. Sex workers participating in a phase II/III triple blind, randomised trial in Benin, Côte d'Ivoire, South Africa, and Thailand were interviewed on the gel's acceptability at monthly scheduled clinic visits. Safer sex counselling, mal...

A local cultural practice that may enhance sexually transmitted infections (STIs) and HIV transmission is vaginal douching and vaginal substance use. These activities also have potential implications for the acceptability of HIV-prevention strategies such as the use of condoms and vaginal microbicides. We aimed to establish the prevalence, determin...

HIV-1 genetic diversity among circulating strains presents a major challenge for HIV-1 vaccine development, particularly for developing countries where less sequence information is available. To identify representative viruses for inclusion in candidate vaccines targeted for South Africa, we applied an efficient sequence survey strategy to samples...

Improved treatment of sexually transmitted infections (STIs) is associated with decreased HIV incidence. However, the success of such programs among HIV-positive sex workers has not been shown. GOAL The goal of the study was to determine the incidence of STIs ( and infections) among HIV-positive sex workers. A cohort of HIV-positive sex workers was...

We aimed to determine the effectiveness of the vaginally administered spermicide nonoxynol-9 (N-9) among women for the prevention of HIV and other sexually transmitted infections (STIs). We did a systematic review of randomised controlled trials. Nine such trials including 5096 women, predominantly sex workers, comparing N-9 with placebo or no trea...

Nonoxynol-9 (rINN, nonoxinol-9) is an over-the-counter spermicide that has in-vitro anti-HIV-1 activity. Results of studies of its effectiveness in prevention of HIV-1 infection in women have been inconclusive. We aimed to assess effectiveness of this vaginal gel. We did a randomised, placebo-controlled, triple-blinded, phase 2/3 trial with COL-149...

Herpes simplex virus type II (HSV-2) is the most common cause of genital ulcer diseases worldwide, 1 and through disruption of the epithelial barrier and inflammation it may increase the risk of HIV-1 transmission. 2 In sub-Saharan Africa, where HIV-1 is spread mainly by heterosexual transmission, other sexually transmitted infections (STIs), inclu...

Clade C is one of the most prevalent genetic subtypes of human immunodeficiency virus type 1 (HIV-1) in the world today and one of the least studied with respect to neutralizing antibodies. Most information on HIV-1 serology as it relates to neutralization is derived from clade B. Clade C primary isolates of HIV-1 from South Africa and Malawi were...

There is a need for female-controlled methods of HIV prevention. Vaginal microbicides, substances inserted into the vagina to prevent women acquiring HIV and sexually transmitted infections (STIs) from men, could be useful in this regard. One potential vaginal microbicide is the widely used spermicide, nonoxynol-9 (N-9). To determine the safety and...

The incidence and prevalence of sexually transmitted infections (STI) and other reproductive tract infections (RTI) is high in much of the developing and parts of the developed worlds. STIs and RTIs are associated with the vaginal transmission of HIV. Additional strategies to improve STI control are needed, and vaginal microbicides are a possible s...

Although the role of mobile populations in the spread of HIV has been documented in several countries, there are few data on HIV among truck drivers in South Africa and the sex workers with whom they interact. To determine HIV prevalence and risk behavior in a sample of truck drivers visiting commercial sex workers at truck stops. Two sex workers f...

Context: With the explosive nature of the South African AIDS epidemic, there is an urgent need for HIV prevention methods controlled by women. Because several microbicide trials are going on in South Africa and elsewhere, there also is an urgent need to determine South African men's perceptions of and preferences for a potential vaginal microbicide...

We have characterized 43 nef sequences from subtype C HIV-1-infected South Africans and compared deduced amino acid sequences with other subtypes to identify areas of conservation. Our Nef amino acid sequences were aligned with a consensus subtype B, HXB2 reference strain and a consensus subtype C sequence. All were found to be highly homologous to...

In this paper we review current guidelines in assuring the rights of study participants and review the experiences in three randomized placebo-controlled double-blinded clinical trials of potential new HIV prevention technologies. The education of study participants to obtain informed consent reducing and monitoring risky behavior during a trial an...

The biosocial background in which the hepatitis B virus (HBV) carrier state with membranous nephropathy (MN) develops was studied by evaluating HBV carriage and proteinuria among 195 family members and household contacts of 31 index HBV carrier children with MN. Unrelated individuals from the communities of these index cases who were negative for H...

Conducting a phase III trial of a vaginal microbicide in a developing country poses several important and complex ethical challenges. As part of a process to bridge the gap between ethical theory and practice, we share our experiences in performing a phase III trial of Col 1492 (Advantage S) among female sex workers at four sites world-wide; Durban...

Human immunodeficiency virus (HIV) type 1-infected (HIV-positive) and -uninfected (HIV-negative) sex workers were examined for the presence of cervical human papillomavirus (HPV) DNA. Cervicovaginal rinse and serum samples from these women were examined for IgG and IgA antibodies to HPV-16 virus-like particles (VLP-16) by ELISA. The HIV-positive wo...

THE EXPLOSIVE AIDS EPIDEMIC IN SOUTH Africa, especially among young women of reproductive age, calls for urgent measures to prevent HIV transmission by such means as vaginal microbicides. This article provides an overview of South Africa's contribution to global microbicide research and development. The research involved focuses mainly on clinical...

COL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a potential microbicide. As part of an effectiveness trial, an initial toxicity study was conducted. The main objective of the reported study was the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a number of times each day by female sex workers. This was a rand...

South Africa is experiencing an explosive epidemic of HIV/AIDS, with about one in four women attending ante-natal clinics nation-wide being HIV-positive. In order to understand the natural history of the epidemic, to design and target intervention to manage it and to evaluate the impact of intervention implemented. It is essential to gather informa...

To compare sexual behavior data obtained using a weekly-recall questionnaire, a daily-recall questionnaire, and a coital diary. Cross-sectional survey of female sex workers from KwaZulu-Natal, South Africa between August and October 1998. In this study, 52 weekly-recall questionnaires, 27 daily-recall questionnaires, and 79 coital diaries for dates...

The purpose of this study was to investigate the prevalence of sexually transmitted infections, including human immunodeficiency virus (HIV), among female sex workers operating at truckstops in the KwaZulu-Natal midlands of South Africa. A total of 145 sex workers were recruited from August 1996 to March 1997. A gynecologic examination, including a...

We studied alcian blue (AB) binding to red blood cells (RBC) [ABRBC] in 89 children and adults with a variety of glomerular diseases. ABRBC was significantly reduced in the group as a whole when compared with healthy controls (P < 0.001). A moderate correlation between the degree of proteinuria and ABRBC was detected in the children with renal dise...

The number and distribution of glomerular anionic sites using polyethyleneimine (PEI) and the ultrastructural changes in the adjacent glomerular basement membrane (GBM) of 33 children with nephrotic syndrome were studied. Compared to the number of PEI-labelled anionic sites in the lamina rara externa per 1000 nm length of the GBM in eight controls...

Although renal biopsy is the definitive investigation in kidney disorders and is particularly helpful in distinguishing steroid-responsive nephrotic syndrome (SRNS) from focal glomerulosclerosis (FGS), it is attended by a small risk to the patient. Accordingly, noninvasive tests have been used to predict the response to steroids and the underlying...

We studied direct and indirect methods of measuring membrane charge by detecting fixed anionic sites with polyethylenimine (PEI) on the glomerular basement membrane (GBM) and Alcian blue on red blood cell (RBC) membrane (ABRBC), respectively, in 40 children with nephrotic syndrome (NS). Size selectivity of the GBM was measured indirectly by fine an...

Sodium dodecyl sulphate polyacrylamide gel electrophoresis (SDS PAGE) of urinary proteins was performed in 56 children with nephrotic syndrome during relapse, of whom 31 had their urines tested within 2 months of the onset of disease. The urines of all 32 steroid-sensitive [presumed minimal change nephrotic syndrome (MCNS)] patients revealed albumi...

Children suffering from kwashiorkor could be grouped as those in whom aflatoxin was detectable in both serum and urine, and those in whom this mycotoxin was undetectable. Examination of the clinical records of the aflatoxin-positive and negative children (58% and 42% of the sample, respectively) showed several other differences between the two grou...

The present investigation has indicated that maize seeds stored under various simulated seasonal conditions show a spectrum of fungi that appear as a succession. The aflatoxin-producing fungus, Aspergillus flavus, is favoured by storage conditions of high temperature and humidity (summer and autumn seasons). This coincides with the more frequent ad...

Severe cachexia of extremely rapid onset typifies the young Black African patient with hepatocellular carcinoma (HCC). In order to assess whether this is a consequence of tumor-associated increases in protein metabolism or simply due to inadequate dietary intake, the following study was undertaken. The technique of constant i.v. infusion of 14C-lab...

Tolerance to an intravenous nutrient infusion containing amino acids, glucose and insulin was assessed in 12 adult patients with clinical and biochemical evidence of liver failure. In six individuals, fasting plasma amino acid patterns and turnover rates were measured by a constant intravenous infusion of [1-14C]leucine tracer. In the remaining pat...

Three metabolically stable patients, receiving total parenteral nutrition as part of their management for post-surgical intestinal fistulae, were studied over a 16-d period in order to assess the effect of two different energy sources on protein metabolism. Nutrient intake was kept constant throughout except for the energy source: for half the time...

The HIV Prevention Research Unit (HPRU) of the Medical Research Council (MRC) in Durban, South Africa, is conducting several HIV prevention studies in the urban and rural areas of KwaZulu-Natal, prompted by the high HIV incidence and prevalence rates within the province. The majority of these HPRU prevention studies are on testing new HIV preventio...

Thesis - (M.Sc.-Biology)-University of Natal, 1990.