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HIV Infections clinical trials

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NCT ID: NCT00160849 Completed - HIV Infections Clinical Trials

Lopinavir/r Monotherapy as Maintenance Therapy After Long Term Viral Suppression

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

1. Objectives Primary - To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent - To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum levels of CD4+ cells. Secondary - To investigate the rate of clinical and laboratorial adverse events in the two treatment groups. - To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups, in case of virological failure of the current regimen. - To describe the adherence to the prescribed regimen in the two treatment groups - To describe changes in body fat distribution (abdominal, arms and thigh circumference) and in the lipid profile, in patients from the two treatment groups - To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups. 2. Patient population: The 60 patients were selected by the investigators according to the study’s inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each. 3. Study design: The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded. 4. Regime: - Group 1 maintenance of the currently used antiretroviral therapy - Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12 hs with food. Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days of therapy (up to Week 2 visit). 5. Duration: 96 weeks of treatment

NCT ID: NCT00160329 Completed - HIV Infections Clinical Trials

Atazanavir or Boosted Atazanavir Substitution for Ritonavir Boosted PI in Patients With Hyperlipidemia

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

The study is looking to compare the impact of lipid levels and HIV viral loads between three different drug regimens: Continuing current regimen (ritonavir boosted regimen), Switching to Atazanavir, or Switching to Atazanavir in combination to Ritonavir.

NCT ID: NCT00159224 Completed - HIV Infections Clinical Trials

Induction-maintenance of Lopinavir/r in HIV-infected Subjects

Start date: April 2005
Phase: Phase 4
Study type: Interventional

This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen. The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1. Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.

NCT ID: NCT00159068 Completed - HIV Infection Clinical Trials

Analysis of Genetic Factors Which May Influence the Course of HIV Infection

Start date: February 2004
Phase: N/A
Study type: Observational

Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body.

NCT ID: NCT00158821 Completed - HIV Infections Clinical Trials

Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.

Start date: March 2000
Phase: Phase 3
Study type: Interventional

To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral drugs and have a viral load of less than 400 copies/mL at week 48.

NCT ID: NCT00158509 Completed - HIV Infection Clinical Trials

Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding

Start date: August 2004
Phase: Phase 2
Study type: Interventional

Genital herpes is a long-life sexually transmitted diseases which infects a large proportion of women in Africa. Its clinical symptoms are painful sores on the genitals, which heals after a few days. HIV infection can worsen genital herpes. In turn, it is possible that genital herpes increases the quantity of HIV secreted at the genital level in women infected by the 2 viruses. This study is dedicated to verify this hypothesis.

NCT ID: NCT00158470 Completed - HIV Infection Clinical Trials

Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)

Start date: September 2003
Phase: Phase 3
Study type: Interventional

Access to care and treatment using antiretroviral drugs will be expanded in Vietnam in the next few years. The ANRS 1210 study is a pilot program to evaluate the feasibility of a simplified antiretroviral treatment using three antiretroviral drugs once a day. The objectives will be to assess the efficacy and the tolerance of this treatment and to better understand the difficulties linked to social and behavioural conditions of patients at different stages during the treatment.

NCT ID: NCT00158457 Completed - HIV Infection Clinical Trials

Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)

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

In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. This combination has already been studied in the North countries. Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.

NCT ID: NCT00158405 Completed - HIV Infections Clinical Trials

Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)

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

Interrupting HAART during limited periods of time ("structured treatment interruption : STI") could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in industrialised countries. This trial aim at assessing the benefits and risks of two different STI strategies in West Africa.

NCT ID: NCT00157170 Completed - HIV Infections Clinical Trials

The Effects of a Supervised Exercise Program on Self Efficacy of People Living With HIV/AIDS.

Start date: September 2002
Phase: N/A
Study type: Interventional

To evaluate the impact of a supervised exercise program (SEP) on self-efficacy,quality of life status and cardiovascular fitness among people with HIV in a 24 week randomised controlled trial.We hypothesised that a combined aerobic and resisted exercise (intervention) would improve these parameters compared to an individual walking program with monthly group forum (control).