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NCT ID: NCT01903031 Completed - HIV-1 Infection Clinical Trials

Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART

Start date: December 30, 2014
Phase: Phase 2
Study type: Interventional

This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. The investigators did not know whether the NuvaRing and ARVs interact when they are used together, so this study looked to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study also included HIV-infected women who were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs. Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, the investigators wanted to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of the female genital tract, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.

NCT ID: NCT01836003 Completed - Pregnancy Clinical Trials

An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana

Start date: July 2011
Phase: N/A
Study type: Interventional

Access to highly active antiretroviral therapy can improve maternal health outcomes for the 4000 HIV- infected women who give birth daily and nearly eliminate transmission of HIV to their infants. However, system inefficiencies, particularly CD4 testing to determine treatment eligibility, are barriers. The project aims to study the effectiveness of a programmatic intervention at improving antenatal access to treatment.

NCT ID: NCT01494038 Completed - HIV Infections Clinical Trials

Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women

Start date: August 19, 2014
Phase: Phase 4
Study type: Interventional

Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income settings and can be a serious complication for HIV-infected pregnant women and their infants. Isoniazid (INH) preventive therapy (IPT) is effective in preventing TB infection in HIV-infected adults, but the safety of IPT in pregnant women is unknown. This study evaluated the safety of IPT among HIV-infected pregnant women.

NCT ID: NCT01427738 Completed - HIV-1 Infection Clinical Trials

Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study was to see which one of two medicines (topical gentian violet [GV] or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC). This was measured by whether the study participant still had OC or sores in his/her mouth after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment of OC were assessed.

NCT ID: NCT01404312 Completed - HIV Infections Clinical Trials

Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

Start date: May 23, 2012
Phase: Phase 3
Study type: Interventional

HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

NCT ID: NCT01315353 Completed - HIV-1 Infection Clinical Trials

HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women

Start date: April 4, 2012
Phase: N/A
Study type: Interventional

Women sometimes develop cancer in an area called the cervix, which is the opening to the uterus, or womb. Women who have HIV are more likely to get this kind of cancer than women who do not have HIV. Nearly all of these cancers are caused by another virus, called human papilloma virus (or HPV). Other times, the cause of this cancer is not known. The investigators are looking for a better way to prevent cervical cancer. This study is comparing two different methods to prevent cancer of the cervix in women who have HIV. This study will also see if these methods are safe and tolerable in women who have HIV.

NCT ID: NCT01302847 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents

Start date: April 20, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy (OBT) in HIV-1 infected infants, children, and adolescents.

NCT ID: NCT01289171 Completed - HIV Clinical Trials

Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients

Start date: January 2009
Phase: N/A
Study type: Interventional

Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat warts that have been recalcitrant to multiple treatments.The aim of this prospective study was to evaluate the efficacy, safety and tolerability of 15% glycolic acid lotion (NeoStrata) for treatment of flat warts in HIV-positive children in Botswana. Additionally, the investigators characterized the flat warts in this population, including Human Papillomavirus (HPV) type(s) and degree of immunosuppression within the patients.

NCT ID: NCT01229761 Completed - HIV Infections Clinical Trials

Study to Improve Survival Among HIV-Exposed Infants in Botswana

Mpepu
Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find ways to improve infant health and survival among infants whose mothers are HIV-infected but who do not themselves have HIV.

NCT ID: NCT01086878 Completed - HIV Infections Clinical Trials

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

Start date: February 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.