A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersen… (NCT00000667) | Clinical Trial Compass
CompletedPhase 1
A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells
United States20 participants
Plain-language summary
To determine the safety of intradermal gp160 in HIV seropositive individuals who are asymptomatic and have a relatively intact immune system. To determine whether there is evidence of a delayed-type hypersensitivity (DTH) response (a "positive" skin test) in these patients, and also the dose of gp160 that elicits a delayed-type hypersensitivity (DTH) response. Early immunity to HIV may play an important role in the long interval between virus infection and the onset of clinical disease. Immune responses have been demonstrated in HIV-infected individuals within weeks to months of infection. Although none of these responses has been shown to be protective, it is possible that boosting anti-HIV immune responses through immunization may slow the progression of HIV infection. DTH responses to HIV-derived recombinant envelope glycoprotein could provide a means of measuring an important immune function in infected patients, and serve as an easily measured surrogate marker of cellular immunity. In addition to eliciting local, cutaneous DTH responses, intradermal inoculation of skin test antigens may be immunogenic, resulting in new antibody production and cellular immune responses. This study allows direct comparison of gp160 administered intradermally with alum-adjuvanted intramuscular preparation with respect to immunogenicity in HIV seropositive patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Concurrent Medication:
Allowed:
* Acute use (\< 14 days) of acyclovir for Herpes simplex virus infections or ketoconazole for symptomatic Candida infections.
Patients must have the following:
* Asymptomatic HIV seropositivity.
* Patients with CD4 counts of 400 - 500 cells/mm3 must be informed of the recommended zidovudine (AZT) therapy and sign an informed consent statement declining AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Systemic symptoms other than lymphadenopathy thought to be due to HIV infection including:
* Fatigue/malaise of \> 1 month duration that interferes with normal activities.
* Fever of \> 100 degrees F persisting for \> 15 in a 30-day interval without definable cause.
* Involuntary weight loss in excess of 10 pounds or \> 10 percent of normal weight within a 6-month interval.
* Diarrhea (\> 3 stools/day) persisting for more than 30 days without definable cause.
* Recurrent oral candidiasis.
* Multidermatomal herpes zoster.
* Biopsy proven hairy leukoplakia.
* Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
Concurrent Medication:
Excluded:
* Antiretroviral agents of proven or potential efficacy.
* Any potential immunoenhancing or immunosuppressive drugs.
Patients with the following are excluded:
* Known hypersensitivity to insect cells or baculovirus.
* Abnormal chest x-ray taken within 3 mon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000667
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)