HIV Infection Clinical Trial
Official title:
A Randomized Trial of CD4 Guided Treatment Interruption, Compared to Continuous Treatment, for HIV Infection
Treatment of HIV repairs the immune system, but continuous treatment is expensive and causes
side effects. Would it not be better to treat intermittently, e.g. stop treatment when the
immune system has recovered, and start again only when damage reappears? That is the
question which STACCATO proposes to answer.
Approximately 500 patients were recruited for this trial from 2002 to 2004. One third were
treated continuously; in two thirds, the treatment was interrupted whenever the CD4 count, a
measure of immune recovery, exceeded 350. At the end of 2005, the two treatment groups will
be compared in order to see which fared better regarding amount of drugs used, side effects,
CD4 counts, and development of resistance to treatment.
Continuous treatment has been very successful in diminishing the diseases and deaths caused
by HIV. However, continuous treatment is expensive. Intermittent treatment will always cost
less than continuous treatment, and therefore has the potential to facilitate access to
highly active antiretroviral therapy (HAART) in developing countries. HAART also causes many
undesirable effects. Intermittent treatment decreases exposure to drugs and is therefore
expected to decrease side effects.
STACCATO is a randomised trial of intermittent versus continuous anti-retroviral treatment.
At least 600 patients on HAART, with viremia below 50 copies/ml and CD4 count above 350
cells/ml were randomised to one of two arms, in 1:2 proportions:
- Arm 1: Continuation (control) arm: Drugs are continued or changed according to current
guidelines and good clinical practice.
- Arm 2: CD4-guided arm: Drugs discontinued and reintroduced according to CD4 counts,
with HAART being administered only if CD4 count is < 350 cells/ml.
Randomized treatment will continue during an average of approximately 2 years, and will be
followed by a period of 12 to 24 weeks’ continuous treatment, for patients in both arms.
Endpoints: The amount of drugs used, side effects, viremia and CD4 counts, number of
clinical events, at the end of the randomized treatment period, and again 12 to 24 weeks
later. A subproject will study the effect of treatment interruption on resistance
development, mutations in proviral DNA and proviral DNA levels.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
| Active, not recruiting |
NCT02663856 -
My Smart Age With HIV: Smartphone Self-assessment of Frailty
|
||
| Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
| Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
| Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
| Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
| Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
| Completed |
NCT02564341 -
Targeting Effective Analgesia in Clinics for HIV - Intervention
|
N/A | |
| Active, not recruiting |
NCT02302950 -
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
|
N/A | |
| Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
| Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
| Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
| Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
| Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
| Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
| Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
| Completed |
NCT02525146 -
Birmingham Access to Care Study
|
N/A | |
| Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
| Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
| Completed |
NCT01805427 -
Antiretroviral Therapy and Extreme Weight
|
N/A |