Phase III PEG-Intron in HIV-infected Patients (Study P00738)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00035360 |
Recruitment Status :
Completed
First Posted : May 6, 2002
Last Update Posted : March 10, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections AIDS | Drug: PEG-Intron | Phase 3 |
This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients.
Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months.
A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | October 2003 |
Actual Study Completion Date : | October 2003 |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV positive
- History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI
- HIV RNA >400-<50,000 copies/mL
- Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN.
Exclusion Criteria:
- Current ribavirin therapy
- Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention
- Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures
- Concomitant use of immunosuppressants or cytotoxic agents
- History of seizure disorder requiring use of anticonvulsants
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00035360 |
Other Study ID Numbers: |
P00738 |
First Posted: | May 6, 2002 Key Record Dates |
Last Update Posted: | March 10, 2017 |
Last Verified: | March 2017 |
PEG-Intron treatment experienced |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Peginterferon alfa-2b Antiviral Agents Anti-Infective Agents |