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NCT ID: NCT03249181 Not yet recruiting - Pregnancy Related Clinical Trials

Dolutegravir in Pregnant HIV Mothers and Their Neonates

DolPHIN-2
Start date: September 2017
Phase: Phase 3
Study type: Interventional

To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late pregnancy. An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens for women commencing cART in late pregnancy. HIV positive pregnant women presenting with untreated HIV infection in late (≥28 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV + 2 NRTIs (SoC)

NCT ID: NCT03237182 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

The Individualized M(X) Drug-resistant TB Treatment Strategy Study

InDEX
Start date: June 14, 2017
Phase: Phase 4
Study type: Interventional

This is a randomized controlled clinical trial comparing treatment success of a gene-derived individualized drug-resistant Tuberculosis regimen to a standard Tuberculosis regimen based on South African National Tuberculosis guidelines.

NCT ID: NCT03227731 Not yet recruiting - HIV-1-infection Clinical Trials

Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women

PrEP
Start date: August 15, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

An Open Label randomized control study. To explore the safety of Truvada when used as PrEP during pregnancy and lactation. Pregnant women considered at risk for HIV infection and willing to participate in this randomized control study will be randomized to commencing PrEP in pregnancy and continued use throughout breastfeeding or deferred PrEP until breastfeeding cessation. All women will receive the standard of care for prevention of HIV and other sexually transmitted infections. Arm A: (Intervention): Standard HIV Prevention strategy PLUS a once daily dose of Truvada (FTC 200mg/TDF 300mg tablet) initiated in pregnancy, continuing until cessation of breastfeeding or 18 months postdelivery whichever is earliest and thereafter the option to continue PrEP post breastfeeding cessation. Arm B: (Control): Standard HIV Prevention strategy throughout pregnancy until cessation of breastfeeding PLUS the offer to initiate PrEP post breastfeeding cessation. Standard HIV prevention strategy includes risk reduction counselling, STI screening and treatment, condom promotion and inviting the sexual partner to receive HCT and referral for ART if he tests positive. Main Outcome Measure: Renal function, pregnancy outcomes, bone health and infant growth. Other Outcome Measure: Incident HIV infections, adherence to PrEP, drug resistance and mother-to-child transmission of HIV.

NCT ID: NCT03225586 Recruiting - Cancer Clinical Trials

Prospective Urban Rural Epidemiology Study

PURE
Start date: January 1, 2002
Phase: N/A
Study type: Observational

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).

NCT ID: NCT03215680 Recruiting - Iodine Deficiency Clinical Trials

Climat Impact on Urinary Iodine Concentration

LION
Start date: July 10, 2017
Phase: N/A
Study type: Observational

Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce urine volume and consequently increase UIC independent of iodine status. This could lead to an overestimation of population iodine intake, thus masking iodine deficiency in vulnerable groups. In this longitudinal observational cohort study in women of reproductive age we will collect 24h and spot urine samples in the summer and winter season. The influence of high temperature climates on UIC, measured and estimated urinary iodine excretion will be estimated.

NCT ID: NCT03201510 Active, not recruiting - HIV Clinical Trials

Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa

Start date: July 2015
Phase: N/A
Study type: Observational

This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).

NCT ID: NCT03200054 Recruiting - Hiv Clinical Trials

Postpartum Adherence Clubs for Antiretroviral Therapy

PACART
Start date: January 2016
Phase: N/A
Study type: Interventional

South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.

NCT ID: NCT03199027 Recruiting - Hiv Clinical Trials

Timing of Referral to Adherence Clubs for Antiretroviral Therapy

TRAC
Start date: January 18, 2017
Phase: N/A
Study type: Interventional

Following the announcement of the global "90-90-90" strategy, there is a huge need in South Africa for effective well-developed scaled-up models of ART (anti-retroviral therapy) delivery that aim to improve patient adherence and viral suppression. The ART adherence club is one such model of service delivery. We are conducting a pragmatic randomised control trial to compare virological outcomes 12 months post-ART initiation between arms: those referred to the Adherence club at 4 months post-ART initiation (early referral) and those referred to the Adherence club at 12 months post-ART initiation (delayed referral). Those with delayed Adherence club referral will continue to attend the ART clinic as per the Standard-of-Care.

NCT ID: NCT03194646 Recruiting - Leiomyoma Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

ASTEROID 6
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

NCT ID: NCT03194308 Not yet recruiting - HIV Prevention Clinical Trials

Safer Conception for Women

Start date: June 2017
Phase: N/A
Study type: Observational

Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.