HIV Infections Clinical Trial
Official title:
A Multiclinic, Open Study to Evaluate the Ability of the Combination of Indinavir, Zidovudine and Lamivudine to Result in Sustained Suppression of HIV-1 in Asymptomatic HIV-1 Seropositive Patients
To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to
suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below
the limit of detection of the most sensitive validated assay (ultradirect assay) and (2)
absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral
mononuclear cells (PBMCs), and semen.
It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will
result in:
1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in
50% of patients who have undetectable viral RNA by the most sensitive validated assay
available (ultradirect assay) for at least 48 weeks.
2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA
to below the limit of detection of the ultradirect assay for at least 48 weeks in at
least 25% of patients.
3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below
the limit of detection of the standard Amplicor assay (i.e., negative) in at least 90%
of patients by Week 16.
4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by
maintenance of serum viral RNA to below the limit of detection of the ultradirect assay
for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in
patients who have maintained this level of suppression for at least 120 weeks on
therapy.
It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will
result in:
1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in
50% of patients who have undetectable viral RNA by the most sensitive validated assay
available (ultradirect assay) for at least 48 weeks.
2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA
to below the limit of detection of the ultradirect assay for at least 48 weeks in at
least 25% of patients.
3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below
the limit of detection of the standard Amplicor assay (i.e., negative) in at least 90%
of patients by Week 16.
4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by
maintenance of serum viral RNA to below the limit of detection of the ultradirect assay
for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in
patients who have maintained this level of suppression for at least 120 weeks on
therapy.
All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks. If
there is no evidence of infectious virus, and patients continue to have serum viral RNA
levels below the limit of detection of the ultradirect assay for at least 96 weeks, therapy
is continued for an additional 24 weeks. However, during this additional 24 weeks of therapy
patients may continue to receive this triple combination drug regimen or make changes to
this drug regimen treatment by reducing their number of antiretroviral agents. After 120
weeks, if patients continue to have serum viral RNA levels below the limit of detection of
the ultradirect assay, patients discontinue all antiretroviral therapy. However, if there is
any evidence of infectious virus, as outlined above, patients do not discontinue therapy.
Patients who develop detectable serum viral RNA following discontinuation of therapy are
given the option to reinitiate therapy with the triple combination of indinavir, zidovudine
and lamivudine. NOTE: Patients who develop an intolerance to zidovudine may use stavudine at
doses per body weight at the direction of the investigator.
;
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
| 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 |