HIV Infections Clinical Trial
Official title:
Comparison of 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine in Therapy of Patients With HIV Infection
To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in
patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4
counts < 200 cells/mm3.
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the
first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.
However, AZT therapy has been associated with significant toxicities. In addition, the
effectiveness of AZT appears to decrease during the second and third years of therapy. For
these reasons, the development of alternative therapy that would be at least as effective
but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits
replication (reproduction) of HIV with less apparent toxicity than AZT.
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the
first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.
However, AZT therapy has been associated with significant toxicities. In addition, the
effectiveness of AZT appears to decrease during the second and third years of therapy. For
these reasons, the development of alternative therapy that would be at least as effective
but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits
replication (reproduction) of HIV with less apparent toxicity than AZT.
AMENDED: 9/28/90 Patients are assigned to one of 2 treatments under a double-blind, randomly
allocated, experimental design if their duration of prior AZT therapy is 0 to 16 weeks.
(Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI
will continue to be dosed at that level, adjusted for weight, and followed as originally
planned.) Patients are assigned to one of 3 treatments as explained prior to this amendment
if their duration of prior to AZT therapy is greater than 16 weeks. Original design:
Patients are assigned to one of three treatments under a double-blind randomly allocated
experimental design. ddI will be administered at two dose levels.
It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4
weeks of the study and monthly thereafter. This study continues for at least 18 months after
the entry of the first subject.
;
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 |