Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda
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ClinicalTrials.gov Identifier: NCT00405821 |
Recruitment Status
:
Completed
First Posted
: November 30, 2006
Results First Posted
: September 28, 2012
Last Update Posted
: September 28, 2012
|
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This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and may make HIV progress faster. The study will evaluate:
"Whether people who take acyclovir can avoid antiretroviral treatment until later in their lives
"Whether people who take acyclovir get fewer genital ulcers
"How well people are able to take acyclovir and any side effects they experience from it
"Differences in the amount of HIV virus in the blood of patients who are and are not taking acyclovir, and how HIV/AIDS is different in these patients.
People 18 years of age and older living in the Rakai district of Uganda who are infected with both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no active ingredient) daily for 2 years. During this time, they visit the clinic once a month for a routine physical examination. Patients who develop genital ulcers or complications of HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to begin antiretroviral therapy, are treated accordingly.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Herpes Genitalis | Drug: Acyclovir Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 440 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir Prophylaxis Versus Placebo Among HIV-1/HSV-2 Co-Infected Individuals in Uganda |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Acyclovir 400mg tablet twice daily |
Drug: Acyclovir
400mg twice daily for 24 months
|
Placebo Comparator: Placebo tablet twice daily |
Drug: Placebo
Placebo tablet twice daily for 24 months
|
- Progression to AIDS (CD4+ Less Than 250 Cells/Microliter or World Health Org Stage IV dx, Excluding Esophageal Candidiasis) [ Time Frame: 2 years ]Evaluate the effect of acyclovir prophylaxis vs placebo among HIV-1/HSV-2 co-infected individuals on the progression to AIDS (CD4+ less than 250 cells/microliter or World Health Org stage IV disease, excluding esophageal candidiasis)
- Difference in Number of Episodes of Genital Ulcer Disease Between Arms [ Time Frame: 2 years ]We calculated incidence rate for each treatment arm for episodes of genital ulcer disease, and incidence rate ratio.
- HIV-1 Viral Load Difference Between Arms [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ]We measured mean annual rate of change in log10 viral load (copies/mL) for each group. We assessed difference in annual rate of change in log10 viral load (copies/mL) between groups.
- Toxicity of Acyclovir [ Time Frame: 2 years ]
- Adherence to Acyclovir [ Time Frame: 2 years ]
- Virologic and Immunologic Responses to ART in Those Who Progress to CD+4 Less Than 250cells/mL [ Time Frame: 6 months and 12 moths post ART initiation ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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INCLUSION CRITERIA:
- Documentation of HIV-1 infection, by either two positive ELISAs or two discrepant ELISAs with a confirmatory positive Western Blot
- Documentation of prior HSV-2 infection by Focus Kalon ELISA
- Absolute CD4+ T-cell count of greater than or equal to 300 and less than or equal to 400 cells/microliter within 30 days prior to randomization
- All participants must be receiving Cotrimoxazole prophylaxis as part of standard care unless contraindicated
- Age at least 18 years and above
-
Laboratory values (within 30 days prior to randomization)
- Aspartate transaminase (AST) no more than five times the upper limit of normal (ULN)
- Total bilirubin no more than 2 times ULN
- Creatinine no more than 2.0 mg/dL
- Platelet count at least 50 000/microliter
- Hemoglobin at least 8g/dL
- Written informed consent
EXCLUSION CRITERIA:
- Concurrent malignancy or any other disease state requiring cytotoxic chemotherapy
- Symptomatic for significant HIV-related illnesses (WHO stage III or IV), such as opportunistic infections and malignancies other than mucocutaneous Kaposi's sarcoma. A history of AIDS defining opportunistic infections other than mucocutaneous Kaposi's sarcoma or candida or treated tuberculosis
- Active HSV-2 disease as suggested by painful genital ulcer disease at time of screening or enrollment
- Current use of antiretroviral medications or Preventing Mother-to-Child Transmission (PMTCT) use of antiretrovirals within the previous 6 months
- Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine medical history, physical examination, or screening laboratory studies.
- Psychiatric illness that, in the opinion of the PI, might interfere with the study compliance.
- Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or patient safety.
- CD4+ count less than 300 or more than 400 cells/microliter.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405821
Uganda | |
Rakai Health Sciences Program, Uganda Virus Research Institute | |
Kalisizo, Rakai District, Uganda |
Principal Investigator: | Steven J Reynolds, MD | National Institute of Allergy and Infectious Diseases (NIAID) |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Steven Reynolds, Scientific Director NIH-Uganda ICER, National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00405821 History of Changes |
Other Study ID Numbers: |
999907032 07-I-N032 ( Other Identifier: NIAID Intramural IRB ) |
First Posted: | November 30, 2006 Key Record Dates |
Results First Posted: | September 28, 2012 |
Last Update Posted: | September 28, 2012 |
Last Verified: | August 2012 |
Keywords provided by Steven Reynolds, National Institutes of Health Clinical Center (CC):
AIDS HIV Disease Progression Quality of Life HIV Viral Load |
Genital Ulcers HIV Treatment Naive |
Additional relevant MeSH terms:
Herpes Genitalis Herpes Simplex HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Herpesviridae Infections DNA Virus Infections Genital Diseases, Male Genital Diseases, Female Acyclovir Antiviral Agents Anti-Infective Agents |