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NCT ID: NCT00485264 Completed - HIV Infections Clinical Trials

Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

Start date: September 17, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.

NCT ID: NCT00448669 Completed - HIV Infections Clinical Trials

Botswana TDF/FTC Oral HIV Prophylaxis Trial

TDF2
Start date: March 2007
Phase: Phase 2/Phase 3
Study type: Interventional

This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.

NCT ID: NCT00384046 Completed - Clinical trials for Hypoactive Sexual Desire Disorder

Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.

NCT ID: NCT00270296 Completed - HIV Infections Clinical Trials

Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV

Start date: June 2006
Phase: Phase 2
Study type: Interventional

Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.

NCT ID: NCT00197691 Completed - HIV Infections Clinical Trials

Botswana Pediatric Respiratory Disease and Bloodstream Infection Study

Start date: March 2001
Phase: N/A
Study type: Observational

The purpose of this study is to learn about lower respiratory tract and bloodstream diseases among infants born to HIV positive mothers in Botswana. Study factors include how commonly infants get these diseases, the causes, and outcomes. The study will also try to measure the protective effect, if any, of breast feeding on respiratory disease illness and deaths.

NCT ID: NCT00197652 Completed - HIV Infections Clinical Trials

Botswana Diarrheal Diseases Study

Start date: March 2001
Phase: N/A
Study type: Observational

The goals of this study are to: 1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers. - analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers. - comparison to rates among infants born to HIV uninfected mothers. 2. link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.

NCT ID: NCT00197613 Completed - HIV Infection Clinical Trials

The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

Start date: December 2002
Phase: Phase 3
Study type: Interventional

The "Adult Antiretroviral Treatment and Resistance Study," hereafter referred to as "The Tshepo Study," is the first large-scale research study of antiretroviral therapy to treat AIDS and HIV infection in Botswana. The Tshepo Study is an open-label, randomized study comparing: (1) the rate of development and specific types of drug resistance mutations with various antiretroviral combination therapies to HIV-1C, the subtype of HIV found in southern Africa, and (2) the short and long-term effectiveness of two operational modifications of Directly Observed Therapy (DOT) medication adherence strategies for antiretroviral therapy. Specifically, treatment follow-up via the Standard of Care, the national standard of care as it evolves in Botswana, with intensive clinic-based follow up including regular adherence education sessions, will be compared to Community-Based Directly Observed Therapy (Com-DOT). Com-DOT involves the SOC with added community or family-based DOT. This Com-DOT component would involve a trained, community or family-based Medication Partner ("mopati") who observes the patient take his or medications daily.

NCT ID: NCT00194519 Completed - HIV Infection Clinical Trials

Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission

Start date: November 2004
Phase: Phase 3
Study type: Interventional

The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 >250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive. Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count >250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed. The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date.

NCT ID: NCT00164281 Completed - HIV Infections Clinical Trials

Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Start date: November 2004
Phase: Phase 4
Study type: Interventional

This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

NCT ID: NCT00149656 Completed - HIV Infections Clinical Trials

The Effects of Nutritional Supplementation and Drug Abuse on HIV

Start date: June 2003
Phase: N/A
Study type: Interventional

The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.