Advertisement

Topics

Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding

2014-08-27 03:16:00 | BioPortfolio

Summary

The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.

Description

A small number of adults (who are not pregnant) and children who take anti-HIV medications develop problems with their kidneys and with the strength of their bones. These problems may be more common when tenofovir disoproxil fumarate (TDF) is used. Studies about these bone and kidney effects have not been done in pregnant and breastfeeding women and their infants.

This is a substudy of a larger study (IMPAACT 1077 PROMISE [Promoting Maternal and Infant Survival Everywhere]) to evaluate the safety of anti-HIV medications used in pregnancy and during breastfeeding. Only participants in the larger study randomly assigned to receive maternal tenofovir disoproxil fumarate (TDF) or no maternal TDF during pregnancy or during breastfeeding will be enrolled in this substudy.

This substudy will look at three groups of participants:

- An antepartum exposure group to look at the effects of TDF during pregnancy (about 450 women-infant pairs)

- A postpartum exposure group to look at the effects of TDF during breastfeeding (about 600 women-infant pairs)

- An antepartum and postpartum group to look at the effects of TDF during both pregnancy and breastfeeding on mothers and their infants

All mother-infant pairs in the substudy will be followed for 74 weeks after delivery. During this time, the women and their infants will have medical checkups and tests. The tests will include tests of blood, urine, cord blood, and breast milk. Some of the women and infants will have a special x-ray called a dual energy e-ray absorptiometry (DXA) scan to measure bone strength. The timing of the tests—at enrollment, at delivery, at 6, 10, 26, or 74 weeks—will vary dependent on which part of this substudy women and infants are enrolled in. Those in charge of the substudy will try to schedule medical visits and tests at the same time as tests scheduled for the larger IMPAACT 1077 study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

HIV Infections

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:00-0400

Clinical Trials [203 Associated Clinical Trials listed on BioPortfolio]

Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological in...

An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complic...

Central Nervous System Infections in Denmark

The Danish Study Group of Infections of the Brain is a collaboration between all departments of infectious diseases in Denmark. The investigators aim to monitor epidemiological trends in c...

Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

Adults admitted to intensive care units are at risk for a variety of complications. One of the most frequent complications is the development of new infections. Infections due to a fungus...

Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial

The purpose of this multicentre prospective trial is to determine the incidence and risk factors for surgical wound infections. Also the investigators will evaluate consequences of wound i...

PubMed Articles [3402 Associated PubMed Articles listed on BioPortfolio]

A New Scoring System to Predict Blood Stream Infections in Patients with Complicated Intra-Abdominal Infections: Experience from a Tertiary Referral Hospital in China.

This purpose of this study was to investigate the effects of blood stream infections (BSIs) on the prognosis of patients with complicated intra-abdominal infections (IAIs) and to make predictions base...

mircoRNA-3162-3p is a potential biomarker to identify new infections in HIV-1-infected patients.

Identification of new HIV infections (HIV incidence) is critical for monitoring AIDS epidemic and assessing the effectiveness of intervention measures. However, current methods for distinguishing new ...

Childhood Infections and Subsequent School Achievement Among 598,553 Danish Children.

Hospitalizations for infections have been associated with subsequent decreased cognitive ability, but it is uncertain if childhood infections influence subsequent scholastic achievement (SA). We aimed...

Systematic reviews of point-of-care tests for the diagnosis of urogenital Chlamydia trachomatis infections.

WHO estimates that 131 million new cases of urogenital Chlamydia trachomatis (CT) infections occur globally every year. Most infections are asymptomatic. Untreated infection in women can lead to sev...

Clinical implications of asymptomatic Plasmodium falciparum infections in Malawi.

Asymptomatic Plasmodium falciparum infections are common in Malawi, however, the implications of these infections for the burden of malaria illness are unknown. Whether asymptomatic infections eventua...

Medical and Biotech [MESH] Definitions

Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.

Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)

Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.

Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.

Infections with viruses of the order MONONEGAVIRALES. The concept includes FILOVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; and RHABDOVIRIDAE INFECTIONS.

More From BioPortfolio on "Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...


Searches Linking to this Trial