Clinical Trials Logo

Filter by:
NCT ID: NCT00000832 Completed - HIV Infections Clinical Trials

A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

Start date: n/a
Phase: Phase 1
Study type: Interventional

To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers. One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

NCT ID: NCT00000833 Completed - HIV Infections Clinical Trials

A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

Start date: n/a
Phase: Phase 1
Study type: Interventional

To compare the safety, toxicity, and tolerance of two doses of ribavirin in combination with didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and compare it to the expected toxicity of ddI monotherapy. To determine the effect of concurrent ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be suitable for a Phase II/III evaluation of ddI/ribavirin. Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI.

NCT ID: NCT00000834 Completed - HIV Infections Clinical Trials

A Phase I Study of Methotrexate for HIV Infection

Start date: n/a
Phase: Phase 1
Study type: Interventional

To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine the dose effective in modulating key markers of immune activation. To determine a dose suitable for Phase II or III evaluation in HIV-infected patients. In HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation.

NCT ID: NCT00000836 Completed - HIV Infections Clinical Trials

A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

Start date: n/a
Phase: Phase 2
Study type: Interventional

To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV retinitis. Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.

NCT ID: NCT00000837 Completed - HIV Infections Clinical Trials

A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if it is safe to give Varivax to HIV-positive children and whether it protects children from infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster). VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine that has been approved for use in healthy children. More research is needed to find out how this vaccine will affect HIV-infected children.

NCT ID: NCT00000838 Completed - HIV Infections Clinical Trials

Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine

Start date: n/a
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy. 3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.

NCT ID: NCT00000839 Completed - HIV Infections Clinical Trials

A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

Start date: n/a
Phase: Phase 1
Study type: Interventional

To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are either intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following maternal treatment with ddI during the third trimester of pregnancy. AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for HIV infection. Although ddI has been approved for use in HIV-infected adults and older children, the safety and pharmacokinetics of ddI in pregnant women has not yet been determined.

NCT ID: NCT00000840 Completed - HIV Infections Clinical Trials

A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA

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

To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout following cessation of long-term zidovudine ( AZT ) therapy. Because viral load (amount of HIV RNA in the plasma) is often used as a measure of the effectiveness of new antiretroviral drugs in clinical trials, a washout period, or cessation of current antiretroviral regimens, is commonly required for study entry to allow for a drug-free steady state of viral load prior to initiation of the new drug. However, the kinetics of the viral rebound following drug withdrawal has not been sufficiently studied, and the proper duration of washout is an estimate.

NCT ID: NCT00000841 Completed - HIV Infections Clinical Trials

A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

Start date: n/a
Phase: Phase 3
Study type: Interventional

To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.

NCT ID: NCT00000842 Completed - HIV Infections Clinical Trials

A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy

Start date: n/a
Phase: Phase 2
Study type: Interventional

To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor ( rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To compare the change in viral load between the double-blind phase baseline and week 4 in placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in viral load compared with viral load changes seen with placebo. Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths, it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy.