scholarly journals HIV-1 Drug Resistance in Subjects with Advanced HIV-1 Infection in Whom Antiretroviral Combination Therapy Is Failing: A Substudy of AIDS Clinical Trials Group Protocol 388

2004 ◽  
Vol 39 (4) ◽  
pp. 552-558 ◽  
Author(s):  
L. M. Demeter ◽  
H. J. Ribaudo ◽  
A. Erice ◽  
S. H. Eshleman ◽  
S. M. Hammer ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Clinical Trials ◽  
Combination Therapy ◽  
Aids Clinical Trials ◽  
Hiv 1

Geographic and Temporal Trends of Transmitted HIV-1 Drug Resistance Among Antiretroviral-Naïve Subjects Screening for Two Clinical Trials in North America and Western Europe

2009 ◽  
Vol 10 (2) ◽  
pp. 94-103 ◽  
Author(s):  
Sibtain Rahim ◽  
Linda M. Fredrick ◽  
Barbara A. da Silva ◽  
Barry Bernstein ◽  
Martin S. King
Keyword(s):  
Drug Resistance ◽  
Clinical Trials ◽  
North America ◽  
Western Europe ◽  
Temporal Trends ◽  
Hiv 1

SENSITIVITY, SPECIFICITY, AND PREDICTIVE VALUE OF PHYSICAL EXAMINATION, CULTURE, AND OTHER LABORATORY STUDIES IN THE DIAGNOSIS DURING EARLY INFANCY OF VERTICALLY ACQUIRED HUMAN IMMUNODEFICIENCY VIRUS INFECTION

PEDIATRICS ◽  
1994 ◽  
Vol 94 (2) ◽  
pp. 274-275
Author(s):  
Susan E. Pacheco ◽  
William T. Shearer
Keyword(s):  
Clinical Trials ◽  
Physical Examination ◽  
Hiv Infection ◽  
Laboratory Studies ◽  
Diagnostic Laboratory ◽  
Predictive Values ◽  
P24 Antigen ◽  
Aids Clinical Trials ◽  
Sensitivity Specificity ◽  
Hiv 1

Purpose of the Study. To determine the HIV vertical transmission rate in an unselected group of infants born to HIV-infected mothers, and to examine the sensitivity, specificity, and positive and negative predictive values of physical examination and diagnostic laboratory studies (HIV culture, serum quantitative immunoglobulins and HIV-1 p24 antigen) in the diagnosis of HIV infection. Study Population. A group of 142 infants referred solely because they were born to HIV-infected mothers were selected for this study. Methods. Epidemiological and clinical data were obtained retrospectively from the Baylor Pediatric AIDS Clinical Trials Group HIV Infection Registry and medical records. The information recorded included results of physical examination and diagnostic laboratory tests (HIV culture, serum quantitative immunoglobulins, and HIV-1 p24 antigen). HIV cultures were performed according to a consensus protocol developed for the National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. Results. Of 142 infants whose HIV infection status was known at the time of the study, 17 (20%) had confirmed infection, and 68 (80%) had seroreverted with no evidence of infection. All HIV-infected infants were at least 3 months old when abnormal physical exam findings became apparent (lymphadenopathy and hepatosplenomegaly), but similar findings were noted in an equal number of HIV-uninfected infants. All infected infants available were HIV culture positive by 6 months of age (16/16). There was no positive cultures reported in the infants who seroreverted (32/32). Elevated immunoglobulins (IgG, IgA, IgM) were present by 6 months of age in a high percentage of infected infants. Nearly one-half of the uninfected infants had elevated immunoglobulin levels during the first 6 months of life, but in 50% of the cases it was IgG alone.

scholarly journals Long-term Outcomes in a Large Randomized Trial of HIV-1 Salvage Therapy: 96-Week Results of AIDS Clinical Trials Group A5241 (OPTIONS)

2019 ◽  
Vol 221 (9) ◽  
pp. 1407-1415 ◽  
Author(s):  
Rajesh T Gandhi ◽  
Karen T Tashima ◽  
Laura M Smeaton ◽  
Vincent Vu ◽  
Justin Ritz ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Salvage Therapy ◽  
Virologic Failure ◽  
Virologic Suppression ◽  
Cumulative Activity ◽  
Antiretroviral Medications ◽  
Resistant Group ◽  
Aids Clinical Trials ◽  
Hiv 1

Abstract Background Short-term (48-week) results of the OPTIONS trial showed that nucleoside reverse transcriptase inhibitors (NRTIs) can be safely omitted from salvage therapy as long as the regimen has a cumulative activity of >2 active antiretroviral medications. The long-term durability of this approach and outcomes in persons who have more-extensive HIV-1 drug resistance are uncertain. Methods Participants with virologic failure and anticipated antiretroviral susceptibility received an optimized regimen and were randomized to omit or add NRTIs. A separate group with more resistance (cumulative activity ≤2 active agents) received an optimized regimen including NRTIs. Results At week 96, among 360 participants randomized to omit or add NRTIs, 70% and 65% had HIV-1 RNA <200 copies/mL, respectively. Virologic failure was uncommon after week 48. Younger age and starting fewer new antiretroviral medications were associated with higher odds of virologic failure. In the highly resistant group, 53% had HIV-1 RNA <200 copies/mL at week 96. Conclusions HIV-1 salvage therapy can safely omit NRTIs without compromising efficacy or durability of response as long as the new regimen has a cumulative activity of >2 active drugs. Younger people and those receiving fewer new antiretrovirals require careful monitoring. Even among individuals with more-extensive resistance, most achieve virologic suppression. Clinical Trials Registration NCT00537394.

scholarly journals Long-Acting Anti-HIV Drugs Targeting HIV-1 Reverse Transcriptase and Integrase

2019 ◽  
Vol 12 (2) ◽  
pp. 62 ◽  
Author(s):  
Kamal Singh ◽  
Stefan G. Sarafianos ◽  
Anders Sönnerborg
Keyword(s):  
Drug Resistance ◽  
Clinical Trials ◽  
Reverse Transcriptase ◽  
Treatment Regimens ◽  
Drug Concentrations ◽  
The Status ◽  
Long Acting ◽  
Major Factors ◽  
Hiv Drugs ◽  
Hiv 1

One of the major factors contributing to HIV-1 drug resistance is suboptimal adherence to combination antiretroviral therapy (cART). Currently, recommended cART for HIV-1 treatment is a three-drug combination, whereas the pre-exposure prophylaxis (PrEP) regimens consist of one or two antivirals. Treatment regimens require adherence to a once or twice (in a subset of patients) daily dose. Long-acting formulations such as injections administered monthly could improve adherence and convenience, and thereby have potential to enhance the chances of expected outcomes, although long-lasting drug concentrations can also contribute to clinical issues like adverse events and development of drug resistance. Globally, two long-acting antivirals have been approved, and fifteen are in clinical trials. More than half of investigational long-acting antivirals target HIV-1 reverse transcriptase (HIV-1 RT) and/or integrase (HIV-1 IN). Here, we discuss the status and potential of long-acting inhibitors, including rilpivirine (RPV), dapivirine (DPV), and 4-ethynyl-2-fluoro-2-deoxyadenosine (EFdA; also known as MK-8591), which target RT, and cabotegravir (CAB), which targets IN. The outcomes of various clinical trials appear quite satisfactory, and the future of long-acting HIV-1 regimens appears bright.

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