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NCT ID: NCT00146445 Completed - HIV Clinical Trials

Behavioral Intervention Trial for HIV-infected Injection Drug Users

Start date: August 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to test whether a ten-session behavioral intervention for HIV-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for HIV infection, increasing access to or utilization of HIV primary health care, and increasing adherence to HIV medications.

NCT ID: NCT00144352 Completed - HIV Clinical Trials

In-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults

Start date: September 2002
Phase: Phase 4
Study type: Interventional

Plasmodium falciparum malaria and HIV are among the most important infectious diseases in sub-Saharan Africa. Approximately two-thirds of the estimated 35 million HIV infected persons live in sub-Saharan Africa. Of the 300-500 million annual cases of malaria infection occurring worldwide, about 90% of P. falciparum infections occur in sub-Saharan Africa, resulting in approximately 1 million deaths, mostly in children under five years of age. It is clear that HIV and malaria are responsible for substantial disease, suffering, and an enormous economic burden on the people who can least afford it. Although a study in 1993 in Tanzania showed significantly higher prevalence of malaria infections in HIV-positive compared to HIV negative adults, until recently there have been few studies showing any association between the two infections. We conducted a study to measure the efficacy of the then-first line antimalarial drug (sulfadoxine-pyrimethamine) among patients in three study arms: those who were HIV negative, those who were HIV infected with CD4 cell counts < 200, and among HIV infected patients with CD4 cell counts >= 200. Our hypothesis is that patients with HIV infection and low CD4 cell count will not respond to antimalarial therapy as well as patients who are HIV infected with higher CD4 cell counts or who are HIV negative.

NCT ID: NCT00143689 Completed - HIV Clinical Trials

NRTI-Sparing Pilot Study

Start date: April 2002
Phase: Phase 4
Study type: Interventional

This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing) regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (Combivir + nevirapine and Combivir + Kaletra). Participants will be randomly assigned to receive one of the following drug combinations: - lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day; - Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day; - Combivir and lopinavir/ritonavir twice a day.

NCT ID: NCT00139178 Completed - HIV Clinical Trials

Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

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

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy. We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir). The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir. The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

NCT ID: NCT00139087 Completed - HIV Clinical Trials

Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.

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

The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.

NCT ID: NCT00137657 Completed - HIV Clinical Trials

Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance

Start date: February 2002
Phase: Phase 4
Study type: Interventional

At least three studies in sub-Saharan Africa have demonstrated a decrease in morbidity or mortality among HIV-infected adults who took daily cotrimoxazole (trimethoprim sulfamethoxazole) [CTX] prophylaxis. Because of the demonstrated beneficial effect, high tolerability and low cost of CTX, the United Nations Programme on HIV/AIDS (UNAIDS) recommends that HIV-infected persons with symptomatic HIV or depressed CD4 counts receive daily CTX. The effect of this recommendation on subsequent development of antimicrobial resistance to antifolates among important pathogens needs to be evaluated. The investigators measured the change in the prevalence of markers of antifolate resistance among P. falciparum, and the change in the prevalence of CTX resistance among S. pneumoniae, and E. coli in HIV-infected individuals receiving CTX daily prophylaxis. In addition, the investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal carriage of CTX resistant S. pneumoniae among children living in households where an HIV-infected adult was receiving CTX daily prophylaxis.

NCT ID: NCT00111358 Completed - HIV Clinical Trials

Study of Lifestyle Modification in HIV Lipodystrophy

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

This study is designed to determine the effects of an intensive lifestyle modification program in patients with HIV and Metabolic Syndrome. The primary endpoints will be improvement in body composition, specifically waist-to-hip ratio (WHR). The secondary endpoints will include improvement of cardiovascular indices, such as total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride cholesterol levels, blood pressure, cardiac enzymes, c-reactive protein (CRP), tissue plasminogen activator (t-PA), plasminogen activator inhibitor (PAI), and insulin and glucose metabolism. We expect that quality of life indices and life skills should also improve with the lifestyle modification program.

NCT ID: NCT00105417 Completed - HIV Infections Clinical Trials

Interluekin-7 to Treat HIV-Infected People Receiving Antiretroviral Treatment

Start date: March 2005
Phase: Phase 1
Study type: Interventional

This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7 protein produced by the body, is safe to use in people infected with HIV. IL-7 is important in immune system function. In humans, it can extend the life of immune cells called T-cells and increase their function and maturation; in mice, it can speed up immune system recovery following chemotherapy of transplantation; and in monkeys, it can make T-cells increase in numbers. If this study shows that IL-7 is safe, other trials will determine if it can improve the numbers or function of T-cells in HIV-infected people. Patients 18 years of age and older with HIV infection who have been taking anti-HIV medications for at least 12 months, whose CD4 counts are at least 100 cells/microliter, and whose viral load is no more than 50,000 copies/milliliter may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, including a blood test for HLA type (a genetic test of markers of the immune system), chest x-ray, electrocardiogram, and ultrasound of the spleen. Participants undergo the following tests and procedures during 9 visits, as follows: Pre-entry visit - Brief physical examination, including examination of lymph nodes and spleen. - Medical history, including questions about current and past medications. - Urine pregnancy test for women who are able to become pregnant. - Blood draw for viral load, immune responses, and other routine safety tests. Entry visit - Complete physical examination, including examination of lymph nodes and spleen. - Routine urine test and urine pregnancy test for women who are able to become pregnant. - Blood draw for viral load, immune responses, and other routine safety tests. - IL-7 dosing. Participants are randomly assigned to receive one of five doses of IL-7 (3, 10, 30, 60 or 100 micrograms per kilogram of body weight) or placebo (a salt solution that does not contain IL-7). The dose may be given in one or more injections, with higher doses possibly requiring as many as seven or eight injections. The injections are given subcutaneously (under the skin), usually in the arm or leg. After the injection, patients are monitored closely for 12 hours for skin or allergic reactions. Blood is drawn before the injection and again at 0.5, 1, 1.5, 2, 2.5, 4, 8 and 12 hours after the injection to check blood levels of the study medication. Follow-up visits Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the injection, then at 14 days, 4 weeks, and 8 weeks after the injection. At most study visits, patients have the following procedures: - Brief physical examination, including examination of lymph nodes and spleen. - Routine urine test and urine pregnancy test for women who are able to become pregnant. - Blood draw for viral load, immune responses, and other routine safety tests. - Blood test to measure the amount of study medication in the blood 1, 2, and 3 days after the injection - Electrocardiogram 1 day after the injection

NCT ID: NCT00079807 Completed - HIV Clinical Trials

Painful HIV Neuropathy and Alpha-Lipoic Acid

Start date: September 2003
Phase: Phase 1/Phase 2
Study type: Interventional

HIV is associated with painful peripheral neuropathy. Disability is often significant. Alpha-Lipoic Acid's antioxidant properties may have benefit in this condition.

NCT ID: NCT00057109 Completed - Quality of Life Clinical Trials

Health Values and Spirituality in Veterans With HIV/AIDS

Start date: n/a
Phase: N/A
Study type: Observational

We have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were HIV-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved.