Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00006153
Other study ID # AIEDRP AI-05-006
Secondary ID 905
Status Terminated
Phase Phase 1
First received August 7, 2000
Last updated July 29, 2008

Study information

Verified date June 2003
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if giving a vaccine (Remune) is effective in HIV-positive patients who are also taking anti-HIV therapy.

Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body. A vaccine called Remune works to stop the virus infection by "boosting" the body's immune cell defense against the HIV virus before the virus enters cells. It also blocks the virus from entering the cells. This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.


Description:

During primary HIV infection, after an initial burst in viral load, the body mounts an immunologic response to viral antigens. It is thought that this initial immune response plays an important role in determining early and long-term suppression of HIV. However, limited information is available regarding the effect of early antiretroviral therapy on immune responses. Therapeutic approaches such as Remune, which augment cell-mediated immunologic responses, may prove to be beneficial in controlling the progression of HIV infection, especially when used in combination with antiretroviral therapy in early infection. Current antiviral drugs work by inhibiting the infection of new cells yet seem to suppress early cell-mediated immune responses. The question is raised as to whether immune-based therapies such as Remune may counteract the suppressive effects of antiretrovirals and slow the progression of infection.

Patients receiving fully suppressive antiretroviral therapy are randomized to add either Remune or an Incomplete Freund's Adjuvant (IFA) control. Vaccinations are administered on Day 1, Week 12, and Week 24. Blood samples are collected at Day 1 and Weeks 4, 12, 16, 24, and 28. Clinical assessment includes lymphocyte proliferative response, cytotoxic T lymphocyte (CTL) memory cell activity, chemokine and cytokine measurements, CD4 count, and viral load. Delayed-type hypersensitivity (DTH) skin tests are performed at Day 1 and Week 28. HIV-1 specific immunogenicity is coordinated with the response to antiretroviral therapy in patients.


Recruitment information / eligibility

Status Terminated
Enrollment 45
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.

- Have been on an anti-HIV drug combination that includes a protease inhibitor for at least 3 months but no longer than 12 months.

- Have 2 consecutive viral loads of less than 50 copies/ml, at least 30 days apart, within 90 days of study entry.

- Are at least 16 years old (consent of parent or guardian required if under 18 years).

- Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Are pregnant or breast-feeding.

- Currently abuse alcohol or drugs.

- Are currently being treated for some types of cancer.

- Have any illness or condition that might interfere with the study or put them at risk.

- Have received a vaccination 6 weeks before study entry.

- Have previously received Remune.

- Are taking medications that affect the immune system within 30 days of study entry.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
HIV-1 Immunogen


Locations

Country Name City State
United States Joanne Santangelo San Diego California

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) The Immune Response Corporation

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2