HIV Infections Clinical Trial
Official title:
A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy
Verified date | February 2018 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
Status | Completed |
Enrollment | 97 |
Est. completion date | August 16, 2017 |
Est. primary completion date | April 6, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 15 Years |
Eligibility |
Major Inclusion Criteria: - Documented laboratory diagnosis of HIV-1 infection - Plasma HIV-1 RNA < 400 copies/mL - Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks - Naive to tenofovir DF Key Inclusion Criteria for the First 96-Week Extension - Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study - <18 years of age (at the start of the extension) - Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant. Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension - Completed of treatment with study drug in the first extension phase - <18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults. Key Exclusion Criteria: - Participants receiving ongoing therapy with any of the following - Nephrotoxic agents - Systemic chemotherapeutic agents - Systemic corticosteroids - Interleukin 2 (IL 2) and other immunomodulating agents - Investigational agents - Pregnant or lactating participants - Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication - Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance - Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening - Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis) - Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures) Note: Other protocol defined Inclusion/ Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Panama | Hospital del Nino | Panama City | |
United Kingdom | Great Ormond Street Hospital | London | |
United Kingdom | Imperial College London, Paediatrics Infectious Diseases | London | |
United States | Children's Diagnostic and Treatment Center, Inc | Fort Lauderdale | Florida |
United States | University of Florida, Jacksonville | Jacksonville | Florida |
United States | Jeffrey Goodman Special Care Clinic | Los Angeles | California |
United States | University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases | Los Angeles | California |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Panama, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug. | 48 weeks | |
Secondary | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) | This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | 48 weeks | |
Secondary | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot) | This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | 48 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF. | 96 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF. | 144 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF. | 192 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF. | 240 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF. | 288 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF. | 336 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF. | 384 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF. | 432 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF. | 480 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF. | 528 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug. | 48 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF. | 96 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF. | 144 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF. | 192 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF. | 240 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF. | 288 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF. | 336 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF. | 384 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF. | 432 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF. | 480 weeks | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF. | 528 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 48 Weeks | This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug. | Baseline and 48 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 96 Weeks | This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF. | Baseline and 96 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 144 Weeks | This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF. | Baseline and 144 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 192 Weeks | This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF. | Baseline and 192 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 240 Weeks | This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF. | Baseline and 240 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 288 Weeks | This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF. | Baseline and 288 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 336 Weeks | This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF. | Baseline and 336 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 384 Weeks | This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF. | Baseline and 384 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 432 Weeks | This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF. | Baseline and 432 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 480 Weeks | This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF. | Baseline and 480 weeks | |
Secondary | Change From Baseline in CD4 Percentage at 528 Weeks | This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF. | Baseline and 528 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks | This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug. | Baseline and 48 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks | This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF. | Baseline and 96 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks | This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF. | Baseline and 144 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks | This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF. | Baseline and 192 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks | This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF. | Baseline and 240 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks | This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF. | Baseline and 288 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks | This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF. | Baseline and 336 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks | This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF. | Baseline and 384 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks | This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF. | Baseline and 432 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks | This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF. | Baseline and 480 weeks | |
Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks | This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF. | Baseline and 528 weeks |
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