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NCT ID: NCT02412436 Completed - Tuberculosis Clinical Trials

PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB

PRIDE-HT
Start date: November 3, 2015
Phase: Phase 2
Study type: Interventional

This study was done to evaluate the effect of HIV and TB treatment on a commonly used birth control method. It enrolled women who were infected with HIV and TB and were taking efavirenz (EFV; Sustiva®; an anti-HIV medication), rifampicin (RIF; an anti-TB medication), and isoniazid (INH; an anti-TB medication). The purpose of this study was to find out the best frequency to give depot medroxyprogesterone acetate (DMPA; a hormonal birth control method that is given as a shot every 3 months) in these women. This study also tried to find out if a 150 mg injection of DMPA was effective in preventing ovulation, the process by which the ovaries (the ovaries are part of the female reproductive system) release an egg for fertilization, for 12 weeks in women who are taking EFV and RIF. Another purpose of this study was to find out if it is safe to take RIF, EFV and DMPA at the same time.

NCT ID: NCT02410772 Completed - Tuberculosis Clinical Trials

TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens

S31/A5349
Start date: January 25, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin. The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine. The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin. Target enrollment is 2500 participants. Each study participant will remain in the study for 18 months in order to include at least 12 months of evaluation of whether the participant's TB recurs.

NCT ID: NCT02358616 Completed - HIV Prevention Clinical Trials

An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial (MTN-003)

Start date: December 2012
Phase:
Study type: Observational

This study is primarily exploratory and is designed to both identify factors that may have affected participant adherence to study product in VOICE, and describe how sexual behaviors, such as anal sex, may have had an effect on product efficacy. As such there is no specific hypothesis that is being tested.

NCT ID: NCT02344290 Completed - HIV Infections Clinical Trials

Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

REPRIEVE
Start date: March 26, 2015
Phase: Phase 3
Study type: Interventional

People infected with HIV are at risk for cardiovascular disease (CVD). This study will evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on antiretroviral therapy (ART). The REPRIEVE trial consists of two parallel identical protocols: - REPRIEVE (A5332) is funded by the NHLBI, with additional infrastructure support provided by the NIAID, and is conducted in U.S and select international sites (approximately 120 sites in 11 countries). - REPRIEVE (EU5332) is co-sponsored by NEAT ID and MGH, and is conducted at 13 sites in Spain.

NCT ID: NCT02256631 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

Start date: June 30, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.

NCT ID: NCT02165202 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis

TMC278LA
Start date: October 2014
Phase: Phase 2
Study type: Interventional

This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.

NCT ID: NCT02038335 Completed - HIV Clinical Trials

HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC

Zim CHIC
Start date: February 2014
Phase:
Study type: Observational

This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV. Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon® or Nexplanon® ) and the copper IUD.

NCT ID: NCT02034214 Completed - HIV Clinical Trials

Shaping the Health of Adolescents in Zimbabwe

SHAZ!
Start date: February 2006
Phase: N/A
Study type: Interventional

The SHAZ! study was a randomized trial that compared a package of life skills education, reproductive health care services, and economic livelihood development to a control package of life skills education and reproductive health care services alone. SHAZ! enrolled young women 16 to 19 years old who had been orphaned and who were currently out of school and not infected with HIV. Individuals participated in the project for up to two years.

NCT ID: NCT02028676 Completed - Clinical trials for Human Immunodeficiency Virus

Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa

ARROW
Start date: March 2007
Phase: Phase 4
Study type: Interventional

The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART): 1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as routine laboratory and clinical monitoring (LCM) for toxicity (haematology/biochemistry) and efficacy (CD4)? 2. Whether induction with four drugs from two ART classes followed by maintenance with three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical outcome? Two secondary objectives were to determine 3. Whether changing from twice daily lamivudine+abacavir to once daily lamivudine+abacavir after 48 weeks on ART will have a similar outcome in terms of virological suppression and will result in improvements in adherence to ART? 4. Whether stopping daily cotrimoxazole prophylaxis in children over 3 years of age who have been on ART for at least 96 weeks has a similar outcome in terms of hospitalisation or death as continuing daily cotrimoxazole?

NCT ID: NCT01990274 Completed - Tuberculosis Clinical Trials

The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa

XACT
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able to readily access clinic services. A standard diagnostics package consisting of smear microscopy and culture (with smear result available the next day) will be compared with a novel diagnostics package involving point-of-care sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects only). The primary outcome is a comparison between the number of culture +ve subjects on TB treatment in each group at the end of two months. A secondary aim is an evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims include using chest X-rays obtained during the study to develop and validate of an computer-aided diagnosis (CAD) software package for TB (together with collaborators in the Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations in the urine of those with TB.