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NCT00013884 · ClinicalTrials.gov registry record · Phase 2
HIV Maintenance Therapy With T-20 During HAART Interruption
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00013884 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants.
The verdict
NCT00013884, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or halting progression of the viral infection towards AIDS. However, this treatment is not problem-oriented. It cannot completely rid the body of virus, and long-term therapy carries a risk of toxicity (harmful side effects). Moreover, the treatment is difficult to adhere to because of the many pills and capsules that must be taken daily. When patients stop taking HAART, their viral levels climb again. This study will see if T-20 can prolong the time it takes for HIV blood levels to rise in patients who stop HAART temporarily. The results may provide insight into possible new HAART-sparing treatments. HIV-infected patients 18 years of age and older who have received HAART for at least 1 month may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly a chest X-ray and electrocardiogram (EKG). Participants will receive either 100 Mg. of T-20 twice a day or 200 Mg. once a day, injected under the skin, and their normal HAART regimen for 3 days. (Patients or a caregiver will be taught how to give the T-20 injections.) On the fourth day, HAART will be stopped and all patients will receive 100 Mg. of T-20 twice a day for 6 weeks. Blood will be drawn weekly from the second to the sixth week after stopping HAART to check viral levels and CD4+ T cell counts. At the end of the 6 weeks, T-20 will be stopped and HAART will be restarted. Patients will then be evaluated once a month until their viral level is less than 50. The final clinic visit will be one month after this time. In addition to blood draws, patients will undergo leukapheresis before beginning T-20 and possibly again when they restart HAART and at the end of the
Interventions
- DRUG T-20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2001-03 |
| Est. Completion | 2003-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00013884
The ClinicalTrials.gov registry entry for NCT00013884 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which T-20 is the first listed.
NCT00013884 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00013884 about?
NCT00013884 is a clinical study titled "HIV Maintenance Therapy With T-20 During HAART Interruption". This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or halting progression of t...
What is the current status of trial NCT00013884?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2001-03. Estimated completion is 2003-04.
What interventions are being tested in trial NCT00013884?
The interventions under investigation include: T-20 (DRUG).
Who is sponsoring clinical trial NCT00013884?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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