Browsing by Author "Nair, Gonasagrie."

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Brief report : dapivirine vaginal ring use does not diminish the effectiveness of hormonal contraception.
(Wolters Kluwer Health., 2017) Balkus, Jennifer E.; Palanee-Phillips, Thesla.; Reddy, Krishnaveni.; Siva, Samantha.; Harkoo, Ishana.; Nakabiito, Clemensia.; Kintu, Kenneth.; Nair, Gonasagrie.; Chappell, Catherine.; Kiweewa, Flavia Matovu.; Kabwigu, Samuel.; Naidoo, Logashvari.; Jeenarain, Nitesha.; Marzinke, Mark Albert.; Soto-Torres, Lydia.; Brown, Elizabeth R.; Baeten, Jared M.
Abstract available in pdf.
Changes to antiretroviral drug regimens during integrated TB-HIV treatment: results of the SAPiT trial.
(International Medical Press., 2014) Naidoo, Anushka.; Naidoo, Kogieleum.; Yende-Zuma, Fortunate Nonhlanhla.; Gengiah, Tanuja Narayansamy.; Padayatchi, Nesri.; Gray, Andrew Lofts.; Bamber, Sheila.; Nair, Gonasagrie.; Abdool Karim, Salim Safurdeen.
Background—Frequency of drug changes in combination antiretroviral therapy among patients starting both tuberculosis (TB) and human immunodeficiency virus (HIV) therapy, as a result of treatment-limiting toxicity or virological failure, is not well established. Methods—Patients in the Starting Antiretroviral Therapy at Three Points in Tuberculosis (SAPiT) trial were randomized to initiate antiretroviral therapy either early or late during TB treatment or after completion of TB treatment. Drug changes due to toxicity (defined as due to grade 3 or 4 adverse events) or virological failure (defined as viral load > 1000 copies/ml on two occasions, taken at least 4 weeks apart) were assessed in these patients. Results—A total of 501 TB-HIV co-infected patients were followed for a mean of 16.0 (95% confidence interval (CI): 15.5 to 16.6) months after antiretroviral therapy (ART) initiation. The standard first-line ARVs used, were efavirenz, lamivudine and didanosine. Individual drug switches for toxicity occurred in 14 patients (incidence rate: 2.1 per 100 person-years; 95% (CI): 1.1 to 3.5), and complete regimen changes due to virological failure in 25 patients (incidence rate: 3.7 per 100 person-years; CI: 2.4 to 5.5). The most common treatment limiting toxicities were neuropsychiatric effects (n=4; 0.8%), elevated transaminase levels and hyperlactatemia (n= 3; 0.6%), and peripheral neuropathy (n=2; 0.4%). Complete regimen change due to treatment failure was more common in patients with CD4+ cell count <50cells/mm3 (p<0.001) at ART initiation and body mass index greater than 25 kg/m2 (p=0.01) at entry into the study. Conclusion—Both drug switches and complete regimen change were uncommon in patients cotreated for TB-HIV with the chosen regimen. Patients with severe immunosuppression need to be monitored carefully, as they were most at risk for treatment failure requiring regimen change.
Characteristics of women enrolled into a randomized clinical trial of dapivirine vaginal ring for HIV-1 prevention.
(Public Library of Science., 2015) Palanee-Phillips, Thesla.; Schwartz, Katie.; Brown, Elizabeth R.; Govender, Vaneshree.; Mgodi, Nyaradzo.; Kiweewa, Flavia Matovu.; Nair, Gonasagrie.; Mhlanga, Felix.; Siva, Samantha.; Bekker, Linda-Gail.; Jeenarain, Nitesha.; Gaffoor, Zakir.; Martinson, Francis E.; Makanani, Bonus.; Naidoo, Sarita.; Pather, Arendevi.; Phillip, Jessica Lyn.; Husnik, Marla J.; van der Straten, Ariane.; Soto-Torres, Lydia.; Baeten, Jared M.
Abstract available in pdf.
A comparison of direct observation of treatment methods used for treating pulmonary tuberculosis in Durban (eThekwini), KwaZulu-Natal.
(2008) Nair, Gonasagrie.; Knight, Stephen.
Introduction Tuberculosis (TB) causes approximately 2 million deaths every year. The problem is escalating explosively in sub-Saharan Africa and is directly related to the increase in the prevalence ofHuman Immunodeficiency Virus infection. South Africa was ranked as having the fourth highest global incidence of TB in 2006. In 1993, the World Health Organization introduced the Directly Observed Treatment Short-Course strategy to increase efficiency of national TB programmes. The Direct Observation of TB therapy element of the strategy has been contentious. An ideal method of direct observation remains elusive and its role in improving adherence is questionable. Aim The purpose ofthis research is to detennine the most effective directly observed method for pulmonary TB offered in an urban area of South Africa. Methods A retrospective cohort analysis was conducted at the Prince Cyril Zulu Communicable Diseases Centre in Durban, KwaZulu-Natal. The study population consisted of adult patients who commenced a course of TB therapy between July 2005 and June 2006. The effect of clinic based, family member, community health worker, lay community health volunteer and workplace based direct observation on TB treatment outcomes, and frequency of recurrence was detennined. A sub analysis was perfonned of the effect of the different methods ofdirect observation in employed patients. Results Workplace based direct observation resulted in a higher frequency of successful treatment outcomes than the other methods of Direct Observation. Being a re treatment patient was the only significant factor associated with recurrence, both for the entire study population and for those who were employed. Discussion The findings of this study are generalizable to other developing countries where challenges in implementation ofan effective TB programme such as poverty, high burden of HIV infection, a migrant population with strong rural ties and reliance on traditional practices to cure illness play a major role. Recommendations There is often no best treatment observer. Every case has to be individually evaluated and the most acceptable and accessible treatment observer chosen. The findings ofthis study strongly suggest that workplace Direct Obse ation can have a significant impact in improving TB treatment outcomes.
HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial.
(Public Library of Science., 2017) Riddler, Sharon Anne.; Husnik, Marla.; Ramjee, Gita.; Premrajh, Anamika.; Tutshana, Bomkazi Onini.; Pather, Arendevi.; Siva, Samantha.; Jeenarain, Nitesha.; Nair, Gonasagrie.; Selepe, Pearl.; Kabwigu, Samuel.; Palanee-Phillips, Thesla.; Panchia, Ravindre.; Mhlanga, Felix.; Levy, Lisa.; Livant, Edward.; Patterson, Karen.; Elharrar, Vanessa.; Balkus, Jennifer E.
Abstract available in pdf.
The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial.
(American College of Physicians., 2012) Naidoo, Kogieleum.; Yende Zuma, Nonhlanhla.; Padayatchi, Nesri.; Naidoo, Kasavan.; Jithoo, Niraksha.; Nair, Gonasagrie.; Bamber, Sheila.; Gengiah, Santhanalakshmi.; El-Sadr, Wafaa M.; Friedland, Gerald H.; Abdool Karim, Salim Safurdeen.
Background: Concerns about the immune reconstitution inflammatory syndrome (IRIS) remain a barrier to antiretroviral therapy (ART) initiation during antituberculosis treatment in co-infected patients. Objective: To assess IRIS incidence, severity, and outcomes relative to the timing of ART initiation in patients with HIV-related tuberculosis. Design: Randomized, open-label clinical trial. (ClinicalTrials.gov registration number: NCT00398996) Setting: An outpatient clinic in Durban, South Africa. Patients: 642 patients co-infected with HIV and tuberculosis. Measurements: In a secondary analysis of the SAPiT (Starting Antiretroviral Therapy at Three Points in Tuberculosis) trial, IRIS was assessed in patients randomly assigned to initiate ART within 4 weeks of tuberculosis treatment initiation (early integrated treatment group), within 4 weeks of completion of the intensive phase of tuberculosis treatment (late integrated treatment group), or within 4 weeks after tuberculosis therapy completion (sequential treatment group). The syndrome was defined as new-onset or worsening symptoms, signs, or radiographic manifestations temporally related to treatment initiation, accompanied by a treatment response. Severity of IRIS, hospitalization, and time to resolution were monitored. Results: Incidence of IRIS was 19.5 (n = 43), 7.5 (n = 18), and 8.1 (n = 19) per 100 person-years in the early integrated, late integrated, and sequential treatment groups, respectively. Among patients with a baseline CD4+ count less than 0.050 × 10.9 cells/L, IRIS incidence was 45.5, 9.7, and 19.7 per 100 person-years in the early integrated, late integrated, and sequential treatment groups, respectively. Incidence of IRIS was higher in the early integrated treatment group than in the late integrated (incidence rate ratio, 2.6 [95% CI, 1.5 to 4.8]; P < 0.001) or sequential (incidence rate ratio, 2.4 [CI, 1.4 to 4.4]; P < 0.001) treatment groups. More severe IRIS cases occurred in the early integrated treatment group than in the other 2 groups (35% vs. 19%; P = 0.179), and patients in the early integrated treatment group had significantly higher hospitalization rates (42% vs. 14%; P = 0.007) and longer time to resolution (70.5 vs. 29.0 days; P = 0.001) than patients in the other 2 groups. Limitations: It was not possible to assess IRIS in more patients in the sequential treatment group (n = 74) than in the late integrated (n = 50) and early integrated (n = 32) treatment groups because of loss to follow-up, withdrawal, or death within 6 months of scheduled ART initiation. This study did not assess IRIS risk in nonambulatory patients or in those with extrapulmonary and smear-negative tuberculosis. Conclusion: Initiation of ART in early stages of tuberculosis treatment resulted in significantly higher IRIS rates, longer time to resolution, and more severe cases of IRIS requiring hospitalization. These findings are particularly relevant to patients initiating ART with a CD4+ count less than 0.050 × 10.9 cells/L, given the increased survival benefit of early ART initiation in this group.
Integration of antiretroviral therapy with tuberculosis treatment.
(Massachusetts Medical Society., 2011) Abdool Karim, Salim Safurdeen.; Naidoo, Kogieleum.; Grobler, Anna Christina.; Padayatchi, Nesri.; Baxter, Cheryl.; Gray, Andrew Lofts.; Gengiah, Tanuja Narayansamy.; Gengiah, Santhanalakshmi.; Naidoo, Anushka.; Jithoo, Niraksha.; Nair, Gonasagrie.; El-Sadr, Wafaa M.; Friedland, Gerald H.; Abdool Karim, Quarraisha.
Background. We previously reported that integrating antiretroviral therapy (ART) with tuberculosis treatment reduces mortality. However, the timing for the initiation of ART during tuberculosis treatment remains unresolved. Methods. We conducted a three-group, open-label, randomized, controlled trial in South Africa involving 642 ambulatory patients, all with tuberculosis (confirmed by a positive sputum smear for acid-fast bacilli), human immunodeficiency virus infection, and a CD4+ T-cell count of less than 500 per cubic millimeter. Findings in the earlier- ART group (ART initiated within 4 weeks after the start of tuberculosis treatment, 214 patients) and later-ART group (ART initiated during the first 4 weeks of the continuation phase of tuberculosis treatment, 215 patients) are presented here. Results. At baseline, the median CD4+ T-cell count was 150 per cubic millimeter, and the median viral load was 161,000 copies per milliliter, with no significant differences between the two groups. The incidence rate of the acquired immunodeficiency syndrome (AIDS) or death was 6.9 cases per 100 person-years in the earlier-ART group (18 cases) as compared with 7.8 per 100 person-years in the later-ART group (19 cases) (incidence-rate ratio, 0.89; 95% confidence interval [CI], 0.44 to 1.79; P = 0.73). However, among patients with CD4+ T-cell counts of less than 50 per cubic millimeter, the incidence rates of AIDS or death were 8.5 and 26.3 cases per 100 person-years, respectively (incidence-rate ratio, 0.32; 95% CI, 0.07 to 1.13; P = 0.06). The incidence rates of the immune reconstitution inflammatory syndrome (IRIS) were 20.1 and 7.7 cases per 100 person-years, respectively (incidence-rate ratio, 2.62; 95% CI, 1.48 to 4.82; P<0.001). Adverse events requiring a switching of antiretroviral drugs occurred in 10 patients in the earlier-ART group and 1 patient in the later-ART group (P = 0.006). Conclusions. Early initiation of ART in patients with CD4+ T-cell counts of less than 50 per cubic millimeter increased AIDS-free survival. Deferral of the initiation of ART to the first 4 weeks of the continuation phase of tuberculosis therapy in those with higher CD4+ T-cell counts reduced the risks of IRIS and other adverse events related to ART without increasing the risk of AIDS or death.
Risk factors for incidence of sexually transmitted infections among women in a human immunodeficiency virus chemoprevention trial : VOICE (MTN-003).
(American Sexually Transmitted Diseases Association., 2017) Chirenje, Zvavahera Mike.; Gundacker, Holly M.; Richardson, Barbra Ann.; Rabe, Lorna K.; Gaffoor, Zakir.; Nair, Gonasagrie.; Mirembe, Brenda Gati.; Piper, Jeanna M.; Hillier, Sharon Louise.; Marrazzo, Jeanne M.
Abstract available in pdf.
Risk of HIV-1 acquisition among women who use different types of injectable progestin contraception in South Africa: a prospective cohort study.
(Elsevier., 2015) Noguchi, Lisa M.; Richardson, Barbra Ann.; Baeten, Jared M.; Hillier, Sharon Louise.; Balkus, Jennifer E.; Chirenje, Zvavahera Mike.; Bunge, Katherine.; Ramjee, Gita.; Nair, Gonasagrie.; Palanee-Phillips, Thesla.; Selepe, Pearl.; van der Straten, Ariane.; Parikh, Urvi M.; Gomez, Kailazarid.; Piper, Jeanna M.; Watts, Heather D.; Marrazzo, Jeanne M.
Abstract available
Tenofovir-based preexposure prophylaxis for HIV infection among African women.
(Massachusetts Medical Society., 2015) Marrazzo, Jeanne M.; Ramjee, Gita.; Richardson, Barbra Ann.; Gomez, Kailazarid.; Mgodi, Nyaradzo.; Nair, Gonasagrie.; Palanee, Thesla.; Nakabiito, Clemensia.; van der Straten, Ariane.; Noguchi, Lisa M.; Hendrix, Craig W.; Dai, James Y.; Ganesh, Shayhana.; Mkhize, Baningi.; Taljaard, Marthinette.; Parikh, Urvi M.; Piper, Jeanna M.; Mâsse, Benoît.; Grossman, Cynthia.; Rooney, James.; Schwartz, Jill L.; Watts, Heather D.; Marzinke, Mark Albert.; Hillier, Sharon Louise.; McGowan, Ian M.; Chirenje, Zvavahera Mike.
Abstract available in pdf.
Timing of initiation of antiretroviral drugs during tuberculosis therapy.
(Massachusetts Medical Society., 2010) Abdool Karim, Salim Safurdeen.; Naidoo, Kogieleum.; Grobler, Anna Christina.; Padayatchi, Nesri.; Baxter, Cheryl.; Gray, Andrew Lofts.; Gengiah, Tanuja Narayansamy.; Nair, Gonasagrie.; Bamber, Sheila.; Singh, Aarthi.; Khan, Munira.; Pienaar, Jacqueline C.; El-Sadr, Wafaa M.; Friedland, Gerald H.; Abdool Karim, Quarraisha.
Background. The rates of death are high among patients with coinfection with tuberculosis and the human immunodeficiency virus (HIV). The optimal timing for the initiation of antiretroviral therapy in relation to tuberculosis therapy remains controversial. Methods. In an open-label, randomized, controlled trial in Durban, South Africa, we assigned 642 patients with both tuberculosis and HIV infection to start antiretroviral therapy either during tuberculosis therapy (in two integrated-therapy groups) or after the completion of such treatment (in one sequential-therapy group). The diagnosis of tuberculosis was based on a positive sputum smear for acid-fast bacilli. Only patients with HIV infection and a CD4+ cell count of less than 500 per cubic millimeter were included. All patients received standard tuberculosis therapy, prophylaxis with trimethoprim–sulfamethoxazole, and a once-daily antiretroviral regimen of didanosine, lamivudine, and efavirenz. The primary end point was death from any cause. Results. This analysis compares data from the sequential-therapy group and the combined integrated-therapy groups up to September 1, 2008, when the data and safety monitoring committee recommended that all patients receive integrated antiretroviral therapy. There was a reduction in the rate of death among the 429 patients in the combined integrated-therapy groups (5.4 deaths per 100 person-years, or 25 deaths), as compared with the 213 patients in the sequential-therapy group (12.1 per 100 person-years, or 27 deaths); a relative reduction of 56% (hazard ratio in the combined integrated-therapy groups, 0.44; 95% confidence interval, 0.25 to 0.79; P = 0.003). Mortality was lower in the combined integrated-therapy groups in all CD4+ count strata. Rates of adverse events during follow-up were similar in the two study groups. Conclusions. The initiation of antiretroviral therapy during tuberculosis therapy significantly improved survival and provides further impetus for the integration of tuberculosis and HIV services. (Clinical Trials.gov number, NCT00398996.)